Categories
Nevin Manimala Statistics

Head-to-head comparisons of 68Ga-PSMA-11 and 18F-FDG PET/CT in evaluating patients with upper tract urothelial carcinoma: a prospective pilot study

Int Urol Nephrol. 2023 Jul 21. doi: 10.1007/s11255-023-03710-1. Online ahead of print.

ABSTRACT

PURPOSE: To prospectively compare the uptake of 68Ga-prostate specific membrane antigen (68Ga-PSMA)-11 and 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) in upper tract urothelial carcinoma (UTUC) and investigate the correlation between radiological parameters and pathological features of UTUC.

METHODS: Clinicopathologic and imaging data were collected from 10 UTUC patients who underwent preoperative 68Ga-PSMA-11 and 18F-FDG PET/CT scans. The diagnostic capabilities of both imaging techniques were analyzed and compared in UTUC. Angiogenesis in the malignancies was assessed using Chalkley counting and the expression of folate hydrolase 1 (FOLH1) and glucose transporter 1 (GLUT1) in UTUC were evaluated in the surgical specimens. Double immunofluorescence staining of PSMA and CD34 was used to examine tumor neovascularization. Tracer uptake and expression were compared and explored. Additionally, 10 patients with clear cell renal cell carcinoma (ccRCC) were included for prospective, comparative research.

RESULTS: Ten UTUC patients with 12 malignant lesions and another 10 ccRCC patients were included. 18F-FDG PET/CT demonstrated a more effective detection of UTUC foci compared to 68Ga-PSMA-11 PET/CT (the SUVmax of 18.48 ± 6.73 vs. 4.38 ± 1.45, P < 0.01). Immunohistochemical analysis revealed a statistically significant difference in the expression of PSMA and GLUT1 in UTUC (P = 0.048), with higher pathological grades showing more intense GLUT1 staining than PSMA (75% vs. 12.5%). The Chalkley counting of angiogenesis in ccRCC was significantly higher than that in UTUC (229.34 vs. 71.67), which was proportional to 68Ga-PSMA-11 PET/CT SUVmax (both P < 0.05).

CONCLUSION: 18F-FDG PET/CT holds better clinical potential for evaluating UTUC and detecting lymph node metastasis compared to 68Ga-PSMA-11 PET/CT, likely due to the relatively scant expression of FOLH1 in tumor neovascular endothelium while the abundant expression of GLUT1 in malignancy. Furthermore, the lower neovascular density in UTUC should not be overlooked.

PMID:37477778 | DOI:10.1007/s11255-023-03710-1

Categories
Nevin Manimala Statistics

Complication rates in very low and extremely low birth weight infants following laparotomy: a prospective study

Pediatr Surg Int. 2023 Jul 21;39(1):237. doi: 10.1007/s00383-023-05520-z.

ABSTRACT

INTRODUCTION: Surgical site occurrences (SSO), including surgical site infection, dehiscence, and incisional hernia, are complications following laparotomy. SSO rates in premature neonates are poorly understood. We hypothesize that SSO rates are higher among extremely low birth weight (ELBW) infants compared to very low birth weight (VLBW) infants and strive to determine the optimal abdominal closure method for these infants.

METHODS: We conducted a prospective observational study of infants < 1.5 kg (kg) undergoing laparotomy at two institutions from 1/1/2020 to 5/1/2022. Patients were grouped by weight and closure; SSO rates were computed and the association tested using Fisher’s exact test.

RESULTS: We identified 59 patients and 104 total operations. At initial surgery, 37 patients weighed < 1 kg (ELBW); 22 patients weighed 1-1.5 kg (VLBW). Complication rate for ELBW was 6(16%) vs. 2(9%) in VLBW, but not significant (p = 0.45). More complications followed a single-layer compared to a two-layer closure (18 vs. 2), but not significant (p = 0.30).

CONCLUSIONS: SSO rates are higher for ELBW infants undergoing laparotomy, and fewer complications follow two-layer closure. However, these findings did not reach statistical significance. Further studies are needed to identify modifiable factors to reduce postoperative complications in these infants.

PMID:37477761 | DOI:10.1007/s00383-023-05520-z

Categories
Nevin Manimala Statistics

Pancreatic CT perfusion: quantitative meta-analysis of disease discrimination, protocol development, and effect of CT parameters

Insights Imaging. 2023 Jul 21;14(1):132. doi: 10.1186/s13244-023-01471-0.

ABSTRACT

BACKGROUND: This study provides a quantitative meta-analysis of pancreatic CT perfusion studies, investigating choice of study parameters, ability for quantitative discrimination of pancreatic diseases, and influence of acquisition and reconstruction parameters on reported results.

METHODS: Based on a PubMed search with key terms ‘pancreas’ or ‘pancreatic,’ ‘dynamic’ or ‘perfusion,’ and ‘computed tomography’ or ‘CT,’ 491 articles published between 1982 and 2020 were screened for inclusion in the study. Inclusion criteria were: reported original data, human subjects, five or more datasets, measurements of pancreas or pancreatic pathologies, and reported quantitative perfusion parameters. Study parameters and reported quantitative measurements were extracted, and heterogeneity of study parameters and trends over time are analyzed. Pooled data were tested with weighted ANOVA and ANCOVA models for differences in perfusion results between normal pancreas, pancreatitis, PDAC (pancreatic ductal adenocarcinoma), and non-PDAC (e.g., neuroendocrine tumors, insulinomas) and based on study parameters.

RESULTS: Reported acquisition parameters were heterogeneous, except for contrast agent amount and injection rate. Tube potential and slice thickness decreased, whereas tube current time product and scan coverage increased over time. Blood flow and blood volume showed significant differences between pathologies (both p < 0.001), unlike permeability (p = 0.11). Study parameters showed a significant effect on reported quantitative measurements (p < 0.05).

CONCLUSIONS: Significant differences in perfusion measurements between pathologies could be shown for pooled data despite observed heterogeneity in study parameters. Statistical analysis indicates most influential parameters for future optimization and standardization of acquisition protocols.

CRITICAL RELEVANCE STATEMENT: Quantitative CT perfusion enables differentiation of pancreatic pathologies despite the heterogeneity of study parameters in current clinical practice.

PMID:37477754 | DOI:10.1186/s13244-023-01471-0

Categories
Nevin Manimala Statistics

Evaluation of fracture behavior in short fiber-reinforced direct and indirect overlay restorations

Clin Oral Investig. 2023 Jul 21. doi: 10.1007/s00784-023-05164-2. Online ahead of print.

ABSTRACT

OBJECTIVES: The aim was to assess how incorporating a short-fiber composite (SFC) core would affect the fracture behavior of direct and indirect overlays. Furthermore, to examine the relationship between the thickness ratio of SFC core to particulate-filled composite (PFC) veneering and the fracture-behavior of bilayered-structured restorations.

MATERIALS AND METHODS: A total of 120 molars were used to create MOD cavities, with palatal cusps removed. Four different groups of direct overlays were then made (n = 15/group), all of which featured a SFC core (everX Flow) with varying thicknesses (0, 1, 4, and 5 mm), as well as a surface layer of PFC (G-aenial Posterior), with the overall thickness of the bilayered-structured restoration set at 5 mm. Additionally, four groups of CAD/CAM restorations were created (Cerasmart 270 and Initial LiSi Block), with or without 2 mm of SFC core reinforcement. Following the fabrication of these restorations, cyclic fatigue aging was carried out for a total of 500,000 cycles, with an applied maximum load (Fmax) of 150 N. Subsequently, each restoration underwent quasi-static loading until fracture. The fracture mode was subsequently evaluated using optical microscopy and SEM.

RESULTS: There were no statistically significant differences (p > 0.05) observed in the fracture resistance of indirect overlays reinforced with a 2-mm SFC core compared to those made solely from restorative materials. Direct overlays constructed using plain SFC or with a 4-mm layer thickness of SFC core exhibited significantly higher fracture resistance values (2674 ± 465 and 2537 ± 561 N) (p < 0.05) when compared to all other groups tested, according to the statistical analysis ANOVA.

CONCLUSIONS: The most effective method for restoring large MOD cavities was found to be direct restoration using SFC either alone or as a bulk core in combination with PFC composite.

CLINICAL RELEVANCE: The use of SFC as bulk reinforcing base will significantly improve the loading performance of directly layered restorations.

PMID:37477724 | DOI:10.1007/s00784-023-05164-2

Categories
Nevin Manimala Statistics

Correlations between sleep problems, core symptoms, and behavioral problems in children and adolescents with autism spectrum disorder: a systematic review and meta-analysis

Eur Child Adolesc Psychiatry. 2023 Jul 21. doi: 10.1007/s00787-023-02253-1. Online ahead of print.

ABSTRACT

Children and adolescents with autism spectrum disorder (ASD) experience various sleep problems. Sleep problems co-occur in a bidirectional relationship with ASD core symptoms and behavioral problems. However, studies on how these three factors are intricately linked to each other are limited. This meta-analysis examined the differential relationship between specific sleep problems, core symptoms, and behavioral problems in this population. This study was registered in PROSPERO (CRD42022339695). We systematically searched the PubMed/MEDLINE, Web of Science, and Scopus databases from inception to April 27, 2022. Observational studies that reported correlations between measures of sleep problems, ASD core symptoms, or ASD behavioral problems were included, and participants aged 18 years or below were enrolled. The correlation coefficient (r) was assessed as the primary effect metric. Total 22 cross-sectional studies were included, which comprised 2655 participants (mean age = 6.60 years old; mean percentage of boys = 80.64%). We found correlations between total sleep problems and total core symptoms (r 0.293 [95% confidence interval – 0.095 to 0.604]), total sleep problems and total behavioral problems (r 0.429 [0.299-0.544]), and total core symptoms and total behavioral problems (r – 0.050 [- 0.177 to 0.079]) and identified statistically significant correlations between specific components of sleep problems, ASD core symptoms, and ASD behavioral problems. Each specific sleep problem showed a unique association with core symptoms and behavioral problems. Sleep problems in ASD should be explored in detail, and the closely linked core symptoms and behavioral problems should be common therapeutic targets.

PMID:37477722 | DOI:10.1007/s00787-023-02253-1

Categories
Nevin Manimala Statistics

Femoral head reduction osteotomy for the treatment of late sequela of Legg-Calvé-Perthes disease and Perthes-like femoral head deformities

J Pediatr Orthop B. 2023 Jul 19. doi: 10.1097/BPB.0000000000001109. Online ahead of print.

ABSTRACT

Femoral head reduction osteotomy (FHRO) was described to treat misshapen femoral head that is causing intraarticular hip pain. The published literature showed discrepancies in patient selection, surgical techniques, and decision to perform concurrent acetabular osteotomy. Very few studies used Standardized Outcome Measures (SOMs). This study aims to describe the technique of FHRO and report the results of our series of 22 patients using SOMs and compare them to former peer-reviewed articles. Twenty-two hips in 22 patients with hip pain caused by mishshapen femoral were treated with FHRO with or without triple pelvic osteotomy (TPO). Patients with poor hip range of motion and significant hip joint arthritis were excluded. The mean patient age was 15.8 (range, 9.2-23.9). Clinical results were reported using the HHS. Radiographical results were reported by comparing Lateral Center Edge Angle (LCEA), extrusion index, Tonnis angle, head size percent, sphericity index, and distance from tip of trochanter to center of femoral head. The mean follow-up was 3.2 years. Only 5 patients received TPO. The HHS showed statistical improvement from 62.0 to 81.6 (The median interquartile range 63.5-88.5). Five patients had HHS less than 70 at the latest follow up. All radiographic parameters except the Tonnis angle, showed statistically significant improvement. FHRO with or without pelvic osteotomy is a good salvage procedure for patients presenting with misshapen femoral head with intraarticular hip pain, who still have good preoperative ROM with no signs of hip arthritis. Level of evidence: IV.

PMID:37477108 | DOI:10.1097/BPB.0000000000001109

Categories
Nevin Manimala Statistics

The sealing effect of magnetic-sealing uterine manipulator in isolated uterus from patients with early-stage cervical cancer: a pre-clinical study

J Gynecol Oncol. 2023 Jul 7. doi: 10.3802/jgo.2023.34.e78. Online ahead of print.

ABSTRACT

OBJECTIVE: Traditional uterine manipulator is considered as the main reason for short survival of patients with early-stage cervical cancer during minimally invasive surgery. This study aims to assess the sealing effect of magnetic-sealing uterine manipulators (MUMs) in isolated uteruses.

METHODS: The study was performed on isolated uterus from patients with early-stage cervical cancer who underwent open abdominal radical hysterectomy between November 2019 to April 2021. Right-angle forceps closure tests (groups 1 and 3) were defined as control tests. One experimental MUM closure test (group 2) and 2 control tests were respectively carried out in each of the isolated uterus. DNA ploidy analysis system was used to observe exfoliated cells. Statistical analysis was performed using Wilcoxon signed-rank test to assess the sealing effect of MUM.

RESULTS: We identified 36 patients. No regional node metastasis was discovered and only one tumor was larger than 4.0 cm in diameter. The mean of exfoliated tumor cells in groups 1, 2, and 3 were 1, 1, and 2, respectively. There was no significant difference in the quantity of exfoliated cells between groups 1 and 3 (p=0.476), so the results of the 2 groups were merged. Subsequently, a significant difference was observed between combined right-angle forceps closure tests and MUM closure tests (p=0.022).

CONCLUSION: The sealing effect of MUM was better than that of right-angle forceps. MUM can effectively seal cervical cancer cells in the cup cover, avoiding the dissemination of tumor cells.

TRIAL REGISTRATION: Chinese Clinical Trial Register Identifier: ChiCTR1900026012.

PMID:37477101 | DOI:10.3802/jgo.2023.34.e78

Categories
Nevin Manimala Statistics

Interproximal tooth cleaning operated by a tactile robot. An in vitro analysis

Int J Comput Dent. 2023 Jul 21;0(0):0. doi: 10.3290/j.ijcd.b4224851. Online ahead of print.

ABSTRACT

AIM: New technologies such as tactile robots and artificial intelligence are about to find their way into clinical practice in dentistry and may contribute to the improvement of oral health care in the future. In this study we hypothesized that a collaborative, tactile robot programmed by a dental student removes interproximal artificial plaque as effectively as a human operator in an in vitro pilot trial.

MATERIAL AND METHODS: Model teeth were fully covered with artificial plaque and set into phantom jaws. First, a robot was programmed by a dental student to perform interproximal cleaning with an interproximal brush. Second, teeth were covered with artificial plaque again and the dental student performed the interproximal cleaning manually. Both experiments were repeated five times. Residual plaque was measured with binary pictures. Surface coverage was reported and comparison of methods was performed with significance defined at a= 0.05.

RESULTS: No statistically significant difference was found in the cleaning result between the robot and the human operator.

CONCLUSION: The results of this in vitro pilot study indicate that a tactile robot with integrated artificial intelligence programmed by a dental student can perform interproximal cleaning as effectively as the dental student. Practical lmplications: In the future, the use of robot assistants to support oral hygiene, e.g., in patients with reduced motor skills or impaired vision may be further investigated.

PMID:37477085 | DOI:10.3290/j.ijcd.b4224851

Categories
Nevin Manimala Statistics

Evaluation of the marginal fit of lithium disilicate single crowns fabricated with the conventional (Emax press) and the CAD/CAM (Emax CAD) method: A systematic review and meta-analysis

Int J Comput Dent. 2023 Jul 21;0(0):0. doi: 10.3290/j.ijcd.b4224643. Online ahead of print.

ABSTRACT

AIM: The purpose of this systematic review and meta-analysis is to evaluate the marginal adaptation of single unit full coverage lithium disilicate fixed dental restorations fabricated with the conventional heat pressed technique and the digital CAD/CAM workflow.

MATERIALS AND METHODS: This study is according to the Preferred Reporting Items for Systematic Reviews and Meta- Analyses (PRISMA) statement. study research was conducted in MEDLINE via PubMed and Cochrane Library databases together with a hand search of studies published until June 2022. The search terms were combining suitable Medical Subject Headings (MeSH terms) together with free text words in single or multiple conjunctions. A modified methodological index was used to assess the risk of bias of the included studies. A random effect model was applied to pool the effect estimates, and further assessment of the heterogeneity across studies using the Q test and the I2 metric was conducted. All statistical analyses were performed using Rstudio software, version 4.1.2, using the “meta” package.

RESULTS: The electronic search and hand search identified 51 articles. Eighteen met the inclusion criteria and were included in the systematic review, 17 of which were in vitro and only one was an in vivo study. However, 17 of the initial 18 could be included in the meta-analysis, due to lack of statistical data in one of the in vitro studies. Statistical analyses were conducted by using the Rstudio software program. Meta-analysis was performed with the random effects model (α=.05). No statistical difference was found between the two fabrication methods (p-value=0.49).

CONCLUSIONS: Although the mean marginal adaptation of lithium disilicate single crowns was found to be better with the heat-pressed technique, there was no statistical significance with the CAD/CAM fabricated restorations and both resulted in a clinically acceptable result. Nonetheless, more clinical studies are needed for safer conclusions.

PMID:37477084 | DOI:10.3290/j.ijcd.b4224643

Categories
Nevin Manimala Statistics

Adherence, per-protocol effects, and the estimands framework

Pharm Stat. 2023 Jul 21. doi: 10.1002/pst.2326. Online ahead of print.

ABSTRACT

In the statistical literature, treatment effects in clinical trials are frequently described as either ITT or per-protocol effects. The estimand given for the per-protocol effect is the effect in adherers, where adherers are typically defined as adhering to the intervention as specified in the trial protocol. This dichotomy of treatment effects is unhelpful when there are in reality multiple treatment effects that can be of clinical interest and relevance. The terms “per-protocol” and “adherence” are confusing to non-statisticians. Protocols always allow for discontinuation of randomized treatment so participants discontinuing have actually followed the protocol. When rescue or additional medication is available, the effect in adherers could mean the effect regardless of use of these medications or the effect in a counterfactual world where the participant did not take the medication. Adherence can mean continuing to be prescribed a treatment or some arbitrary level of compliance with a medication that has been prescribed. The ICH E9 (R1) estimands framework provides an improved alternative for the description of treatment effects in clinical trials. Identification of important intercurrent events and the strategy used to handle these events is key to determining the treatment effect. When designing a trial, estimands should be properly defined according to this framework. It is time the statistical literature abandoned describing treatment effects as the effect in adherers or the per-protocol effect.

PMID:37477077 | DOI:10.1002/pst.2326