Tag: statistics

Int J Hyperthermia. 2023;40(1):2250936. doi: 10.1080/02656736.2023.2250936.

ABSTRACT

OBJECTIVE: To investigate the efficacy and adverse effects of focused ultrasound (FU) in the treatment of high-grade squamous intraepithelial lesions (HSIL) and follow up on pregnancy outcomes in patients.

METHODS: This retrospective study recruited 57 patients aged 20-40 years with cervical HSIL combined with HR-HPV infection who received FU treatment between September 2019 and April 2022. Clinical data of the patients were obtained from hospital records. HSIL cure rate and cumulative HR-HPV clearance rate were assessed after treatment. Patients were followed up on fertility and pregnancy outcomes after treatment by telephone interviews until April 1, 2023.

RESULTS: During a 6-month follow-up, the HSIL cure rate was 73.7%, and a statistical difference between CIN2 and CIN3 (75.6% vs. 66.7%, p = 0.713) was not present. HSIL -recurrence was not observed during the follow-up period, and the median follow-up duration was 12 months. The cumulative HR-HPV clearance rates at the 6- and 12-month follow-ups were 56.1% and 75.4%, respectively. The median clearance time of HR-HPV was 6 (95% confidence interval, 5.46-6.54) months. The clearance rate was higher in HPV16/18 than in non-HPV16/18 (86.7% vs. 62.9%, p = 0.038). After treatment, the successful pregnancy rate in patients with fertility intentions and spontaneous abortion rate were 73.9% and 5.9%, respectively. Preterm birth, preterm premature rupture of membranes, or low-birth-weight infants were not observed.

CONCLUSION: FU treatment can regress HSIL and accelerate HR-HPV clearance in young women of childbearing age with cervical HSIL associated with HR-HPV infection, and has no significant adverse effects on pregnancy outcomes.

PMID:37666493 | DOI:10.1080/02656736.2023.2250936

Mech Ageing Dev. 2023 Sep 2:111860. doi: 10.1016/j.mad.2023.111860. Online ahead of print.

ABSTRACT

The purpose of this study was to evaluate texture-based muscle ultrasound image analysis for the assessment and risk prediction of frailty phenotype. This retrospective study of prospectively acquired data included 101 participants who underwent ultrasound scanning of the anterior thigh. Participants were subdivided according to frailty phenotype and were followed up for two years. Primary and secondary outcome measures were death and comorbidity, respectively. Forty-three texture features were computed from the rectus femoris and the vastus intermedius muscles using statistical methods. Model performance was evaluated by computing the area under the receiver operating characteristic curve (AUC) while outcome prediction was evaluated using regression analysis. Models developed achieved a moderate to good AUC (0.67 ≤ AUC ≤ 0.79) for categorizing frailty. The stepwise multiple logistic regression analysis demonstrated that they correctly classified 70 to 87% of the cases. The models were associated with increased comorbidity (0.01 ≤ p ≤ 0.18) and were predictive of death for pre-frail and frail participants (0.001 ≤ p ≤ 0.016). In conclusion, texture analysis can be useful to identify frailty and assess risk prediction (i.e. mortality) using texture features extracted from muscle ultrasound images in combination with a machine learning approach.

PMID:37666473 | DOI:10.1016/j.mad.2023.111860

Ann Anat. 2023 Sep 2:152157. doi: 10.1016/j.aanat.2023.152157. Online ahead of print.

ABSTRACT

BACKGROUND: Porcine liver is widely used in hepatologic research as a large animal model with many anatomical and physiological similarities with humans. However, only limited information on porcine liver spatial microstructure has been published, especially regarding the hepatic sinusoids and bile canaliculi. The aim of our study was to quantify the sinusoidal and bile canalicular network in healthy male and female porcine livers and to map the variability of these structures with heterogenous distribution to improve the evaluability of liver biopsy samples.

METHODS: Livers from 12 healthy piglets (6 females and 6 neutered males) were sampled into 36 tissue samples per organ, representing six hepatic lobes and three different regions related to the hepatic vasculature (peripheral, paracaval and paraportal region). Histological sections were processed with a random orientation of the cutting plane. The endothelium and the bile canaliculi were stained using Ricinus communis agglutinin I lectin histochemistry. The length densities of hepatic sinusoids L_V(sinusoids,liver), of bile canaliculi L_V(bile canaliculi,liver) and volume fraction V_V(sinusoids,liver) and surface density S_V(sinusoids,liver) of sinusoids were estimated using stereological methods. The newly acquired morphometric data were compared with previously published data on density of porcine hepatocytes and fractions of connective tissue.

RESULTS: The peripheral region had smallest L_V(sinusoids,liver), smallest L_V(bile canaliculi,liver) and greatest V_V(sinusoids,liver). The six hepatic lobes had statistically comparable length densities of both sinusoids and bile canaliculi, but the left lateral lobe had smallest V_V(sinusoids,liver). Regions with greater L_V(sinusoids,liver) had also greater L_V(bile canaliculi,liver) and S_V(sinusoids,liver) and were accompanied by greater density of smaller hepatocytes. Regions with smaller L_V(sinusoids,liver) and L_V(bile canaliculi,liver) contained a greater fraction of interlobular connective tissue.

CONCLUSIONS: The length density of hepatic sinusoids is smaller in the peripheral regions of the porcine liver than in other regions related to the hepatic vasculature – paracaval and paraportal regions and smaller in castrated males than in females. Greater length density of liver sinusoids was linked with greater local density of bile canaliculi, with local increase in the density of smaller hepatocytes and, simultaneously, with smaller fractions of hepatic connective tissue. The intrahepatic and inter-sexual variability of the porcine liver morphology needs to be taken into account when designing and interpreting experiments involving the histological quantification of the microvascular network. The complete primary morphometric data describing the distribution of morphometric parameters within porcine liver were made available in a form facilitating the power analysis to justify the minimal number of tissue samples or animals required when designing further histological evaluation studies. The macroscopic map of microvessels and bile canaliculi variability facilitates their assessment in liver biopsies in the pig.

PMID:37666463 | DOI:10.1016/j.aanat.2023.152157

Neuroimage. 2023 Sep 2:120354. doi: 10.1016/j.neuroimage.2023.120354. Online ahead of print.

ABSTRACT

Hyperscanning is a form of neuroimaging experiment where the brains of two or more participants are imaged simultaneously whilst they interact. Within the domain of social neuroscience, hyperscanning is increasingly used to measure inter-brain coupling (IBC) and explore how brain responses change in tandem during social interaction. In addition to cognitive research, some have suggested that quantification of the interplay between interacting participants can be used as a biomarker for a variety of cognitive mechanisms aswell as to investigate mental health and developmental conditions including schizophrenia, social anxiety and autism. However, many different methods have been used to quantify brain coupling and this can lead to questions about comparability across studies and reduce research reproducibility. Here, we review methods for quantifying IBC, and suggest some ways moving forward. Following the PRISMA guidelines, we reviewed 215 hyperscanning studies, across four different brain imaging modalities: functional near-infrared spectroscopy (fNIRS), functional magnetic resonance (fMRI), electroencephalography (EEG) and magnetoencephalography (MEG). Overall, the review identified a total of 27 different methods used to compute IBC. The most common hyperscanning modality is fNIRS, used by 119 studies, 89 of which adopted wavelet coherence. Based on the results of this literature survey, we first report summary statistics of the hyperscanning field, followed by a brief overview of each signal that is obtained from each neuroimaging modality used in hyperscanning. We then discuss the rationale, assumptions and suitability of each method to different modalities which can be used to investigate IBC. Finally, we discuss issues surrounding the interpretation of each method.

PMID:37666393 | DOI:10.1016/j.neuroimage.2023.120354

Photodiagnosis Photodyn Ther. 2023 Sep 2:103789. doi: 10.1016/j.pdpdt.2023.103789. Online ahead of print.

ABSTRACT

PURPOSE: This study aims to investigate the correlation between macular thickness, retinal nerve fiber layer thickness, ganglion cell complex thickness, and Gensini scores in patients who have undergone coronary angiography, using spectral-domain optical coherence tomography.

METHODS: We retrospectively evaluated optical coherence tomography results from patients who had undergone coronary angiography between January 2019 and January 2021 due to coronary artery disease, with angiography performed within one month of the optical coherence tomography examination. Based on their Gensini scores, patients were classified into two groups: mild coronary artery disease (Gensini score ≤ 20, Group 1) and severe coronary artery disease (Gensini score > 20, Group 2).

RESULTS: Group 1 comprised 28 patients with an average age of 61.3±10.2, while Group 2 consisted of 25 patients with an average age of 65.4±9.6. While there was no statistically significant difference found in retinal nerve fiber layer and macular thickness between the groups, the ganglion cell complex thickness was significantly thinner in Group 2 in the inner superior temporal (112.55±34.12 µm vs. 99.68±37.81 µm, p= 0.026), inner superior nasal (121.14±32.92 µm vs. 108.36±24.53 µm, p=0.012), inner inferior nasal (120.81±32.34 µm vs. 108.45±12.53 µm, p=0.048), and superior (99.11±25.91 µm vs. 88.77±16.75 µm, p=0.020) regions. Furthermore, a significant negative correlation was observed between the Gensini score and the ganglion cell complex thickness in both the inner superior nasal and superior regions.

CONCLUSION: Compared to patients with mild coronary artery disease, those with severe disease exhibited a significant decrease in ganglion cell complex thickness in the superior and inner superior nasal regions.

PMID:37666380 | DOI:10.1016/j.pdpdt.2023.103789

J Ethnopharmacol. 2023 Sep 2:117120. doi: 10.1016/j.jep.2023.117120. Online ahead of print.

ABSTRACT

ETHNOPHARMACOLOGICAL RELEVANCE: Ethnopharmacological relevance: Dried and mature seeds of Vaccaria segetalis (Neck.) Garcke ex Asch. (VS) are known for their therapeutic effects, as they stimulate blood circulation, promote menstruation and diuresis and eliminate gonorrhoea. However, due to its hard shell, the dissolution of its active ingredients is often improved by steaming and frying in clinical applications. Among the processed products, wine-steamed Vaccaria segetalis (WVS) is one of the commonly used ones. Numerous historical records have shown that wine steaming can enhance the efficacy of drugs to promote blood circulation and remove blood stasis. However, the differences in the efficacy of VS and WVS in promoting blood circulation and removing blood stasis have not been thoroughly studied, and the possible reasons for these differences have not been reported.

AIM OF THE STUDY: The objective of this study was to identify quality markers (Q-markers) that could differentiate the efficacy of promoting blood circulation and removing blood stasis of VS and WVS, which could serve as a basis for the rational application of VS and WVS in clinical settings.

MATERIALS AND METHODS: A pharmacodynamic comparison between the water extracts of VS and WVS was carried out based on a mouse acute blood stasis model (ABS) and thrombus zebrafish model. The potential bioactive substances of WVS were screened by investigating the correlation between common peaks identified for 10 batches of WVS by ultra-performance liquid chromatography quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF-MS/MS) and their rate of thrombosis inhibition in zebrafish. Furthermore, multivariate statistical analysis of chemical components between VS and WVS was conducted to speculate the Q-markers combined with the results of the bioactive components. Based on the efficacy verification of Q-markers, the content of Q-markers in 10 batches of WVS was evaluated.

RESULTS: The results of efficacy comparison assays demonstrated that the efficacy of WVS was more prominent than VS at the same dose. 5 components were screened as effective components of WVS for promoting blood circulation and removing blood stasis by correlation analysis. Furthermore, a total of 24 common ingredients were identified in VS and WVS extracts, and 9 of them showed increased dissolution rate after wine steaming, including 4 active ingredients, Hypaphorine, Vaccarin, Saponarin, and Isovitexin-2″-O-arabinoside, which were screened out by correlation analysis. The monomer test suggested that these 4 components could activate blood circulation and remove blood stasis in a dose-dependent manner. Consequently, Hypaphorine, Vaccarin, Saponarin, and Isovitexin-2″-O-arabinoside were selected as Q-markers to distinguish between VS and WVS. The content determination showed that the total contents of 4 Q-markers of WVS from 10 batches with different origins ranged from 0.478% to 0.716%.

CONCLUSIONS: This study compared the efficacy of VS and WVS in promoting blood circulation and resolving stasis and revealed Q-markers that reflected the difference in efficacy between them for the first time, which laid the foundation for establishing quality standards for WVS.

PMID:37666377 | DOI:10.1016/j.jep.2023.117120

J Pain Symptom Manage. 2023 Sep 2:S0885-3924(23)00661-9. doi: 10.1016/j.jpainsymman.2023.08.020. Online ahead of print.

ABSTRACT

The CONSORT guideline defines a pilot trial as a small-scale version of a desired future efficacy trial that is intended to answer the key questions of whether and how a larger study should be done. For example, a pilot trial might evaluate willingness of participants to undergo randomization or test different instruments for measuring an outcome. In addition to assessing feasibility of a future study, many investigators use pilot trials to obtain preliminary estimates of efficacy that might be used to gauge the promise of a new intervention, or to use in grant proposals to justify research funding. However, pilot trials do not provide reliable information about intervention efficacy due to the statistical phenomenon called sampling variability. In this brief tutorial we use computer simulation to demonstrate the influence of sampling variability on estimates of efficacy from pilot trials. The simulations show how pilot trial results can lead to erroneous decision making using a survival endpoint in a parallel arm clinical trial as an example. No background in programming or mathematics is required to understand the example. However, R code is provided for interested readers.

PMID:37666368 | DOI:10.1016/j.jpainsymman.2023.08.020

Neurotoxicol Teratol. 2023 Sep 2:107292. doi: 10.1016/j.ntt.2023.107292. Online ahead of print.

ABSTRACT

AIM: To describe the neurodevelopmental phenotype of older children and adults with a diagnosis of Fetal Valproate Spectrum Disorder (FVSD).

METHODS: In this cross-sectional study, 90 caregivers were recruited and completed a series of questionnaires regarding the neurodevelopmental outcomes of 146 individuals aged 7-37 years (M = 18.1), including individuals with a formal diagnosis of FVSD (n = 99), individuals exposed to Valproate but without an FVSD diagnosis (n = 24), and individuals not exposed to Valproate (N = 23). The mean dose of valproate exposure for individuals with an FVSD diagnosis was 1470 mg/day.

RESULTS: Individuals with a diagnosis FVSD showed significantly higher levels of moderate (43.4%) and severe (14.4%) cognitive impairment than other groups (p = 0.003), high levels of required formal educational support (77.6%), and poorer academic competence than individuals not exposed to Valproate (p = 0.001). Overall psychosocial problems (p = 0.02), internalising problems (p = 0.05) and attention problems (p = 0.001), but not externalising problems, were elevated in individuals with a diagnosis of FVSD. Rates of neurodevelopmental disorders, particularly autistic spectrum conditions (62.9%) and sensory problems (80.6%) are particularly central to the FVSD phenotype. There was no evidence of a statistical dose-dependent effect, possibly due to the high mean dose of exposure having a uniformly negative impact across the sample. Individuals with FVSD had required a significant number of health and child development services.

INTERPRETATION: Children and young adults with a diagnosis of FVSD are at an increased risk of a range of altered neurodevelopmental outcomes, highlighting the need for a multidisciplinary approach to clinical management across the lifespan.

PMID:37666366 | DOI:10.1016/j.ntt.2023.107292

Exp Hematol. 2023 Sep 2:S0301-472X(23)01675-2. doi: 10.1016/j.exphem.2023.08.007. Online ahead of print.

ABSTRACT

Autologous hematopoietic stem cell transplantation (auto-SCT) is the recommended treatment for responding multiple myeloma (MM) patients. However, we do not know the risk factors influencing long-term survival without progression after auto-SCT. Therefore, this prospective study aimed to investigate the influence of transplanted cells with cluster of differentiation (CD)184+ expression, CD26+ lymphocyte and monocyte, and reconstitution lymphocytes CD3+ on overall survival (OS) and progression-free survival (PFS) after auto-SCT in MM. Forty-eight patients with MM underwent auto-SCT at our center from 2011 to 2013. The numbers of CD184+ cells, CD26+ lymphocytes, and CD26+ monocytes were measured in the harvested material. In addition, the number of lymphocyte subpopulations (CD3+ lymphocytes, helpers, suppressors, natural killer (NK), cytotoxic NK, and B lymphocytes) was measured in peripheral blood during regeneration after auto-SCT. Flow cytometry was performed in both cases. The median OS was 92 months. Our analysis revealed a statistically significant effect of the number of transplanted CD184+ cells on OS and a statistically significant correlation between PFS and the number of transplanted CD184+ cells and reconstitution of CD3+ lymphocytes. In conclusion, our study showed that the increasing numbers of transplanted CD184+ cells, CD26+ lymphocytes, and CD26+ monocytes augmented the risk of death.

PMID:37666354 | DOI:10.1016/j.exphem.2023.08.007

Ann Thorac Surg. 2023 Sep 2:S0003-4975(23)00919-0. doi: 10.1016/j.athoracsur.2023.08.019. Online ahead of print.

ABSTRACT

BACKGROUND: In 2016, we reported promising mid-term outcomes of the bicuspid pulmonary valve replacement using 0.1-mm polytetrafluoroethylene (PTFE) membrane. This follow-up study analyzes long-term outcomes and risk factors for reintervention and structural valve deterioration (SVD).

METHODS: We performed a retrospective review of the original 119 patients who underwent PTFE bicuspid pulmonary valve replacement. The median age was 16.9 years (range 0.4 to 57.1 years). Reintervention was defined as any surgical or percutaneous catheter procedure on the PTFE valve. SVD was defined as development of a peak pressure gradient ≥ 50 mmHg or ≥ moderate amount of pulmonary regurgitation on follow-up echocardiography.

RESULTS: The median follow-up duration was 9.5 years. The survival rate was 96.5% at 5 and 10 years, with 2 early and 2 late mortalities. Freedom from reintervention was 90.0% at 5 years and 63.3% at 10 years. Freedom from SVD was 92.8% at 5 years and 51.1% at 10 years, with regurgitation being the predominant mode (64.6%). Freedom from both reintervention and SVD at 5 and 10 years were 89.1% and 49.5%, respectively. Multivariable analysis identified smaller valve diameter (hazard ratio 0.82, p<0.001) and more than trivial pulmonary regurgitation at discharge (hazard ratio 5.81, p<0.001) as risk factors for reintervention or SVD.

CONCLUSIONS: Long-term results of the PTFE bicuspid PVR were acceptable. However, improvements may be needed to reduce technical error and improve durability. Smaller valve diameter and more than trivial pulmonary regurgitation at discharge were risk factors for reintervention or SVD, warranting careful follow-up for timely reintervention.

PMID:37666352 | DOI:10.1016/j.athoracsur.2023.08.019