Tag: statistics

JAMA. 2023 Oct 12. doi: 10.1001/jama.2023.20820. Online ahead of print.

ABSTRACT

IMPORTANCE: Blood collection for laboratory testing in intensive care unit (ICU) patients is a modifiable contributor to anemia and red blood cell (RBC) transfusion. Most blood withdrawn is not required for analysis and is discarded.

OBJECTIVE: To determine whether transitioning from standard-volume to small-volume vacuum tubes for blood collection in ICUs reduces RBC transfusion without compromising laboratory testing procedures.

DESIGN, SETTING, AND PARTICIPANTS: Stepped-wedge cluster randomized trial in 25 adult medical-surgical ICUs in Canada (February 5, 2019 to January21, 2021).

INTERVENTIONS: ICUs were randomized to transition from standard-volume (n = 10 940) to small-volume tubes (n = 10 261) for laboratory testing.

MAIN OUTCOMES AND MEASURES: The primary outcome was RBC transfusion (units per patient per ICU stay). Secondary outcomes were patients receiving at least 1 RBC transfusion, hemoglobin decrease during ICU stay (adjusted for RBC transfusion), specimens with insufficient volume for testing, length of stay in the ICU and hospital, and mortality in the ICU and hospital. The primary analysis included patients admitted for 48 hours or more, excluding those admitted during a 5.5-month COVID-19-related trial hiatus.

RESULTS: In the primary analysis of 21 201 patients (mean age, 63.5 years; 39.9% female), which excluded 6210 patients admitted during the early COVID-19 pandemic, there was no significant difference in RBC units per patient per ICU stay (relative risk [RR], 0.91 [95% CI, 0.79 to 1.05]; P = .19; absolute reduction of 7.24 RBC units/100 patients per ICU stay [95% CI, -3.28 to 19.44]). In a prespecified secondary analysis (n = 27 411 patients), RBC units per patient per ICU stay decreased after transition from standard-volume to small-volume tubes (RR, 0.88 [95% CI, 0.77 to 1.00]; P = .04; absolute reduction of 9.84 RBC units/100 patients per ICU stay [95% CI, 0.24 to 20.76]). Median decrease in transfusion-adjusted hemoglobin was not statistically different in the primary population (mean difference, 0.10 g/dL [95% CI, -0.04 to 0.23]) and lower in the secondary population (mean difference, 0.17 g/dL [95% CI, 0.05 to 0.29]). Specimens with insufficient quantity for analysis were rare (≤0.03%) before and after transition.

CONCLUSIONS AND RELEVANCE: Use of small-volume blood collection tubes in the ICU may decrease RBC transfusions without affecting laboratory analysis.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03578419.

PMID:37824152 | DOI:10.1001/jama.2023.20820

Invest Ophthalmol Vis Sci. 2023 Oct 3;64(13):20. doi: 10.1167/iovs.64.13.20.

ABSTRACT

PURPOSE: The purpose of this study was to investigate the foveal changes occurring in multiple evanescent white dot syndrome (MEWDS) using multimodal imaging techniques with a specific focus on hyper-reflective dots (HRDs).

METHODS: This was a retro-prospective observational study including 35 eyes with active MEWDS. Structural and en face optical coherence tomography (OCT) was performed, with follow-up visits at 2 weeks, 6 weeks, and 2 months from baseline. HRD percentage area (HRD % area) was calculated in a 600 µm fovea centered circle on en face OCT, after background subtraction and image binarization. HRD % area was compared with 23 fellow control eyes. Longitudinal changes in the HRD % areas were assessed using repeated-measure statistics.

RESULTS: HRDs were observed as scattered hyper-reflective spots on the vitreoretinal interface on en face OCT images, colocalizing with HRDs or vertical hyper-reflective lines on structural OCT images. The baseline evaluation showed a significantly higher HRD % area in MEWDS eyes compared to fellow eyes (0.10 ± 0.03 vs. 0.08 ± 0.04, P = 0.01). The HRD % area correlated positively with LogMAR visual acuity and inversely with the duration of symptoms. Longitudinal analysis revealed a significant reduction in the HRD % area over time. There was no significant interaction between the rate of HRD disappearance and clinical or demographic factors at baseline.

CONCLUSIONS: As HRD potentially represents the end-feet projections of activated Müller cells on the retinal surface, this study supports the involvement of Müller cells in the pathogenesis of the disease. The findings highlight the potential of en face OCT imaging for monitoring the progression of MEWDS.

PMID:37824135 | DOI:10.1167/iovs.64.13.20

JAMA. 2023 Oct 12. doi: 10.1001/jama.2023.20850. Online ahead of print.

ABSTRACT

IMPORTANCE: Bleeding is the most common cause of preventable death after trauma.

OBJECTIVE: To determine the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) when used in the emergency department along with standard care vs standard care alone on mortality in trauma patients with exsanguinating hemorrhage.

DESIGN, SETTING, AND PARTICIPANTS: Pragmatic, bayesian, randomized clinical trial conducted at 16 major trauma centers in the UK. Patients aged 16 years or older with exsanguinating hemorrhage were enrolled between October 2017 and March 2022 and followed up for 90 days.

INTERVENTION: Patients were randomly assigned (1:1 allocation) to a strategy that included REBOA and standard care (n = 46) or standard care alone (n = 44).

MAIN OUTCOMES AND MEASURES: The primary outcome was all-cause mortality at 90 days. Ten secondary outcomes included mortality at 6 months, while in the hospital, and within 24 hours, 6 hours, or 3 hours; the need for definitive hemorrhage control procedures; time to commencement of definitive hemorrhage control procedures; complications; length of stay; blood product use; and cause of death.

RESULTS: Of the 90 patients (median age, 41 years [IQR, 31-59 years]; 62 [69%] were male; and the median Injury Severity Score was 41 [IQR, 29-50]) randomized, 89 were included in the primary outcome analysis because 1 patient in the standard care alone group declined to provide consent for continued participation and data collection 4 days after enrollment. At 90 days, 25 of 46 patients (54%) had experienced all-cause mortality in the REBOA and standard care group vs 18 of 43 patients (42%) in the standard care alone group (odds ratio [OR], 1.58 [95% credible interval, 0.72-3.52]; posterior probability of an OR >1 [indicating increased odds of death with REBOA], 86.9%). Among the 10 secondary outcomes, the ORs for mortality and the posterior probabilities of an OR greater than 1 for 6-month, in-hospital, and 24-, 6-, or 3-hour mortality were all increased in the REBOA and standard care group, and the ORs were increased with earlier mortality end points. There were more deaths due to bleeding in the REBOA and standard care group (8 of 25 patients [32%]) than in standard care alone group (3 of 18 patients [17%]), and most occurred within 24 hours.

CONCLUSIONS AND RELEVANCE: In trauma patients with exsanguinating hemorrhage, a strategy of REBOA and standard care in the emergency department does not reduce, and may increase, mortality compared with standard care alone.

TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN16184981.

PMID:37824132 | DOI:10.1001/jama.2023.20850

Int J Prosthodont. 2023 Oct 12;0(0). doi: 10.11607/ijp.8516. Online ahead of print.

ABSTRACT

PURPOSE: A Comparison of Occlusal Schemes with Condylar Inclination and Anterior Guidance in Dentate Individuals Methods. Twenty-six dentate patients between the ages of 18 to 30 of Indian Origin with canine-guided occlusion and 26 patients with group function occlusion were included in the study. The School of Articulator Munich (SAM) Axioquick system was used to assess the condylar guidance and eccentric tracings of the patients. For analyses, Student’s t-test was used. For quantitative data, the mean and standard deviation were calculated. For all the statistical analysis the probability of type-I error of 0.05 was considered statistically significant.

RESULTS: The mean condylar guidance for canine guided and group function occlusion on the right side was 38.4 ±12.7 and 30.5 ±12.5 and on the left side was 36.5 ±13.0 and 27.5±12.0 degrees with statistically significant difference [P value: 0.01]. The condylar guidance, incisal guidance, Bennett angle, protrusion, left lateral, right lateral, and left and right lateral angles were analyzed statistically between the two types of occlusions. The results showed a statistically significant difference between the two groups for all parameters except right condylar guidance. Furthermore, all the parameters were higher in canine guided occlusion group over group function occlusion.

CONCLUSIONS: Within the study limitations, it was concluded that the condylar guidance was steeper in canine guided occlusion than in group function occlusion. The eccentric parameters were steeper in canine guided occlusion than in group function occlusion.

CLINICAL SIGNIFICANCE: This study showcases that the condylar guidance might not play a major role in determining the occlusal scheme but, the incisal guidance determines the occlusal scheme predominantly in class 1 occlusion patients.

PMID:37824122 | DOI:10.11607/ijp.8516

Development. 2023 Oct 12:dev.201704. doi: 10.1242/dev.201704. Online ahead of print.

ABSTRACT

The amino acid L-proline exhibits novel growth factor-like properties during development – from improving blastocyst development to driving neurogenesis in vitro. Addition of 400 µM L-proline to self-renewal medium drives naïve mouse embryonic stem cells (ESCs) to early primitive ectoderm-like (EPL) cells – a transcriptionally distinct primed or partially primed pluripotent state. EPL cells retain expression of pluripotency genes, upregulate primitive ectoderm markers, undergo a morphological change, and have increased cell number. These changes are facilitated by a complex signalling network hinging on the Mapk, Fgfr, Pi3k and mTor pathways. Here, we use a factorial experimental design coupled with statistical modelling to understand which signalling pathways are involved in the transition between ESCs and EPL cells, and how they underpin changes in morphology, cell number, apoptosis, proliferation, and gene expression. This approach reveals pathways which work antagonistically or synergistically. Most properties were affected by more than one inhibitor, and each inhibitor blocked specific aspects of the naïve-to-primed transition. These mechanisms underpin progression of stem cells across the in vitro pluripotency continuum and serve as a model for pre-, peri- and post-implantation embryogenesis.

PMID:37823343 | DOI:10.1242/dev.201704

Diagn Cytopathol. 2023 Oct 12. doi: 10.1002/dc.25239. Online ahead of print.

ABSTRACT

OBJECTIVE: The study explores various factors, including coronavirus disease 2019 (COVID-19) history and vaccination status, that influence the classification value of ultrasonography-guided thyroid fine needle aspiration biopsy (TFNAB) by comparing non-diagnostic (Bethesda-I) and diagnostic (Bethesda II-VI) results.

METHODS: We conducted a retrospective observational study in a high-volume tertiary care center involving patients who underwent TFNAB from November 2022 to April 2023. The study retrospectively analyzed the cytopathology of 482 thyroid nodules. Patients were categorized into non-diagnostic (n = 136) and Diagnostic groups (n = 346) based on TFNAB. A comprehensive set of parameters was examined, including demographic, anthropometric and clinical data, thyroid ultrasonography findings, COVID-19 history and immunization status.

RESULTS: The mean age was 55.1 ± 12.1 years in the non-diagnostic group and 53.5 ± 13 years in the Diagnostic group (p = .223). 75.7% (n = 103) of the non-Diagnostic group and 82.9% (n = 287) of the Diagnostic group were male (p = .070). The mean nodule longitudinal diameter of the Diagnostic group was significantly higher than that of the non-diagnostic group (p = .015). The TIRADS score of the nodules showed a statistical difference between the groups (p = .048). The groups had no significant differences regarding other ultrasonographic parameters and COVID-19-related variables.

CONCLUSION: It can be assumed that when the longitudinal diameter of the thyroid nodule is small and in TIRADS categories other than the TIRADS3 category, TFNAB is less likely to be diagnostic. However, future research may be needed to confirm these findings and uncover any long-term effects of COVID-19 or vaccines on thyroid nodule diagnostics.

PMID:37823334 | DOI:10.1002/dc.25239

J Prosthodont. 2023 Oct 12. doi: 10.1111/jopr.13783. Online ahead of print.

ABSTRACT

PURPOSE: To compare the effect of different pre-cementation surface treatments and bonding protocols on the retention force of additively manufactured (AM) implant-supported interim crowns.

MATERIAL AND METHODS: A total of 50 AM interim crowns (Temporary CB resin) were cemented on implant abutments. Five groups (n = 10) were established based on the different surface pre-treatments performed in the intaglio surface of the specimens: no surface pre-treatment (Group C or control), air-abraded with 50-μm aluminium oxide particles (Group AP)_, air-abraded with 50-μm aluminium oxide particles followed by the application of silane (Group AMP), silane (Group MP), and air-abraded with 30μm silica-coated aluminum oxide particles followed by the application of silane (Group CMP). Each specimen was cemented into an implant abutment using a composite resin cement (Rely X Unicem2). Afterward, the specimens underwent retention testing with a Universal Instron machine. Pull-off forces (N) and modes of failure were registered. Statistical analysis was performed using Mann-Whitney U tests with Bonferroni corrections for multiple tests (α = .05).

RESULTS: The median retention force values were 233.27 ±79.28 N for Group Control, 398.59 ±68.59 N for Group MP, 303.21 ±116.80 N for Group AMP, 349.31 ±167.73 N for Group CMP, and 219.85 ± 55.88 N for Group AP. The pull-off forces were significantly greater for Group MP, while the differences between the remaining groups were not statistically significant (P>0.05). Group AP showed the lowest retention force values among all the groups. Failure modes after the pull-off testing were predominantly adhesive and substrate failure of the AM interim material.

CONCLUSIONS: The surface treatment of the intaglio AM crown tested significantly influenced the retention force values measured. Pre-treatment with an MDP-containing silane improved the retentive force values computed, whereas pre-treatment with 50-μm Al₂ O₃ air-particle abrasion alone is not recommended prior to cementation on a titanium-based implant abutment. This article is protected by copyright. All rights reserved.

PMID:37823323 | DOI:10.1111/jopr.13783

Med Oral Patol Oral Cir Bucal. 2023 Oct 12:25861. doi: 10.4317/medoral.25861. Online ahead of print.

ABSTRACT

BACKGROUND: Oral Lichen Planus is a potential malignant disorder and shares clinical and histopathological features with other similar lesions. ALDH1 is a specific biomarker for stem cells identification, however its role in stromal cells of immune inflammatory infiltrate has not been explored. The aim of this study was to investigate the ALDH1 immunoexpression in epithelial and stromal cells of Oral Lichen Planus and other lesions with lichenoid inflammatory infiltrate.

MATERIAL AND METHODS: 64 samples of Oral Lichen Planus, Oral Lichenoid Lesions, Oral Leukoplakia and Unspecific Chronic Inflammation were included. ALDH1 was evaluated in both epithelium and stromal cells. ALDH1+ cells ≥ 5% were considered positive in epithelium. Stromal cells were evaluated semi quantitatively. Fields were ranked in scores, according to criteria: 1 (0 to 10%); 2 (11 to 50%) and 3 (>50%). The mean value of the sum of the fields was the final score. Statistical differences among groups were investigated, considering p < 0.05.

RESULTS: ALDH1 expression in epithelium was low in all groups without difference among them. ALDH1+ cells in the lamina propria were higher for Lichen Planus [2.0], followed by Leukoplakia [1.3], Lichenoid lesions [1.2] and control [1.1] (p<0.05).

CONCLUSIONS: ALDH1 immunoexpression in epithelium of lichenoid potential malignant disorders did not show a contributory tool, however ALDH1 in stromal cells of lichen planus might be involved in the complex process of immune regulation associated with the pathogenesis of this disease.

PMID:37823302 | DOI:10.4317/medoral.25861

Med Oral Patol Oral Cir Bucal. 2023 Oct 12:26170. doi: 10.4317/medoral.26170. Online ahead of print.

ABSTRACT

BACKGROUND: The present study aimed to evaluate the ultrasonographic findings of submandibular and submental lymph nodes in patients with and without odontogenic infection.

MATERIAL AND METHODS: Systemically healthy patients aged 18-30 years old with or without odontogenic infections were included in this study. Clinical examinations were performed on all patients; those with any odontogenic infection were placed in the study group, and those without were placed in the control group. Ultrasonographic examinations of bilateral submental and submandibular lymph nodes were performed for both groups. The data were statistically analyzed using Pearson’s Chi-square test and Student’s t-test.

RESULTS: A total of 150 patients voluntarily participated (female: n=86 (57%), male: n=64 (43%)), 75 in the study group and 75 in the control group. During the ultrasonographic examination, patients in the study group had more than one lymph node the same patient was mostly detected, in the study group (right submandibular: n=42, 56%, and left submandibular: n=43, 57.3%). The long-axis diameter of the submandibular lymph nodes was 9.305.30 mm and 5.505.20 mm in the study and control groups, respectively.

CONCLUSIONS: Ultrasonography revealed that the presence, number, and long-axis diameter of the submandibular lymph nodes in the patients with and without odontogenic infection were statistically different.

PMID:37823301 | DOI:10.4317/medoral.26170

Med Oral Patol Oral Cir Bucal. 2023 Oct 12:26193. doi: 10.4317/medoral.26193. Online ahead of print.

ABSTRACT

BACKGROUND: The transcutaneous electrical nerve stimulation (TENS) stimulus inhibits the activity of nociceptive neurons of the central nervous system. Pain relief is achieved by increasing the pulse amplitude of TENS to induce a non-painful paranesthesia beneath the electrodes. This study aimed to assess the effect of TENS on acute pain, edema, and trismus after surgical removal of impacted third molars.

MATERIAL AND METHODS: This randomized, double blind, split-mouth clinical trial was conducted on 37 patients with bilaterally impacted mandibular third molars. The angle and body of mandible at the site of surgery in one randomly selected quadrant underwent TENS immediately after surgery (50 Hz, 100-µs short pulse, 15 minutes for 6 days). The TENS stimulator device was used in off mode for the placebo quadrant. The pain score (primary outcome) was measured for 7 days postoperatively, and edema and trismus (secondary outcomes) were assessed at 2, 4 and 7 days, postoperatively. The results were analyzed by repeated measures ANOVA using R software (alpha=0.05).

RESULTS: The overall mean pain score was significantly lower in the TENS than the placebo group (P<0.05). The number of taken analgesics in the first 3 days was significantly lower in the TENS group (P<0.001). Postoperative edema in the TENS group was lower than the placebo group but only the difference was not statistically significant (P>.05). The inter-incisal distance, as an index to assess trismus, was not significantly different between the two group at day 2, but it was significantly higher in the TENS group after the second day (P<0.001).

CONCLUSIONS: TENS effectively decreased pain and trismus following impacted third molar surgery, and may be recommended as a non-pharmaceutical method to relieve postoperative symptoms.

PMID:37823292 | DOI:10.4317/medoral.26193