Category: Statistics

Zhonghua Yi Xue Za Zhi. 2024 May 7;104(17):1493-1498. doi: 10.3760/cma.j.cn112137-20231213-01374.

ABSTRACT

Objective: To investigate the effect and safety of transnasal humidified rapid insufflation ventilatory exchange (THRIVE) technique in hysteroscopic diagnostic and therapeutic surgery. Methods: This study was a randomized controlled trial. A total of 100 female patients undergoing hysteroscopy surgery at Beijing Tongren Hospital from September to December 2023 were selected and randomly divided into two groups by the random number table method: the THRIVE group and the mask oxygen group, with 50 patients in each group. Patients in both groups were given total intravenous anesthesia with propofol combined with remifentanil and preserved spontaneous respiration. The THRIVE group was given oxygen by the THRIVE device with an oxygen flow rate of 50 L/min, while the mask oxygen group was given oxygen by the mask with an oxygen flow rate of 5 L/min; the oxygen concentration of both groups was set at 100%. The general condition of the patients, vital signs during the operation, the amount of anesthesia drugs used and the operation time were recorded. The primary observation index was the incidence of hypoxic events in the two groups; the secondary observation indexes were the incidence and time of intraoperative apnea as well as the corresponding oxygenation interventions and the incidence of non-hypoxic adverse events. Results: The age of the THRIVE group was (42±14) years, and the age of the mask oxygen group was (43±15) years. The duration of surgery in the THRIVE group was (15.9±3.4) min, which was statistically lower than that of the mask oxygen group (16.3±4.5) min (P=0.041), and there were no differences observed in the duration of awakening time and anesthesia time (both P>0.05). There was no significant difference in the dosage of propofol, remifentanil, and intraoperative vasoactive drugs between the two groups (all P>0.05). The SpO₂ of the patients in the THRIVE group at the end of the operation was (99.7±1.1) %, which was higher than that of the mask-oxygen group (99.1±1.1) % (P<0.05). There was no difference in SpO₂ of the two groups at the other time points (all P>0.05). There were no differences in HR and MAP of two group patients at each time point (all P>0.05). The incidence of hypoxic events in the THRIVE group was 12.0% (6/50), which was lower than that of 28.0% (14/50) in the mask oxygen group (P=0.045). The difference in the incidence and duration of apnea between the two groups was not statistically significant (all P>0.05). There were no cases of temporary need for laryngeal mask or tracheal intubation during surgery in both groups. There was no statistically significant difference in the incidence of intraoperative body movement, dizziness, nausea and vomiting between the two groups (all P>0.05), and no cardiac, cerebral, renal or other important organ insufficiency occurred in the two weeks after surgery. Conclusion: THRIVE technology can provide effective oxygenation for patients undergoing hysteroscopic diagnosis and treatment, maintain patients’ circulatory stability, and improve the safety and efficiency of surgery.

PMID:38706056 | DOI:10.3760/cma.j.cn112137-20231213-01374

BMC Womens Health. 2024 May 5;24(1):275. doi: 10.1186/s12905-024-03079-y.

ABSTRACT

BACKGROUND: In this study we shed light on ongoing trends in contraceptive use in Flanders (Belgium). Building on the fundamental cause theory and social diffusion of innovation theory, we examine socio-economic gradients in contraceptive use and the relationship to health behaviours.

METHODS: Using the unique and recently collected (2020) ISALA data, we used multinomial logistic regression to model the uptake of contraceptives and its association to educational level and health behaviour (N:4316 women).

RESULTS: Higher educated women, and women with a healthy lifestyle especially, tend to use non-hormonal contraceptives or perceived lower-dosage hormonal contraceptives that are still trustworthy from a medical point of view. Moreover, we identified a potentially vulnerable group in terms of health as our results indicate that women who do not engage in preventive health behaviours are more likely to use no, or no modern, contraceptive method.

DISCUSSION: The fact that higher educated women and women with a healthy lifestyle are less likely to use hormonal contraceptive methods is in line with patient empowerment, as women no longer necessarily follow recommendations by healthcare professionals, and there is a growing demand for naturalness in Western societies.

CONCLUSION: The results of this study can therefore be used to inform policy makers and reproductive healthcare professionals, since up-to-date understanding of women’s contraceptive choices is clearly needed in order to develop effective strategies to prevent sexually transmitted infections and unplanned pregnancies, and in which women can take control over their sexuality and fertility in a comfortable and pleasurable way.

PMID:38706007 | DOI:10.1186/s12905-024-03079-y

Epigenetics Chromatin. 2024 May 6;17(1):13. doi: 10.1186/s13072-024-00528-8.

ABSTRACT

BACKGROUND: Multiple studies have demonstrated a negative correlation between gene expression and positioning of genes at the nuclear envelope (NE) lined by nuclear lamina, but the exact relationship remains unclear, especially in light of the highly stochastic, transient nature of the gene association with the NE.

RESULTS: In this paper, we ask whether there is a causal, systematic, genome-wide relationship between the expression levels of the groups of genes in topologically associating domains (TADs) of Drosophila nuclei and the probabilities of TADs to be found at the NE. To investigate the nature of this possible relationship, we combine a coarse-grained dynamic model of the entire Drosophila nucleus with genome-wide gene expression data; we analyze the TAD averaged transcription levels of genes against the probabilities of individual TADs to be in contact with the NE in the control and lamins-depleted nuclei. Our findings demonstrate that, within the statistical error margin, the stochastic positioning of Drosophila melanogaster TADs at the NE does not, by itself, systematically affect the mean level of gene expression in these TADs, while the expected negative correlation is confirmed. The correlation is weak and disappears completely for TADs not containing lamina-associated domains (LADs) or TADs containing LADs, considered separately. Verifiable hypotheses regarding the underlying mechanism for the presence of the correlation without causality are discussed. These include the possibility that the epigenetic marks and affinity to the NE of a TAD are determined by various non-mutually exclusive mechanisms and remain relatively stable during interphase.

CONCLUSIONS: At the level of TADs, the probability of chromatin being in contact with the nuclear envelope has no systematic, causal effect on the transcription level in Drosophila. The conclusion is reached by combining model-derived time-evolution of TAD locations within the nucleus with their experimental gene expression levels.

PMID:38705995 | DOI:10.1186/s13072-024-00528-8

BMC Surg. 2024 May 5;24(1):135. doi: 10.1186/s12893-024-02418-y.

ABSTRACT

BACKGROUND: The endoscopic endonasal transsphenoidal approach (EETA) has revolutionized skull-base surgery; however, it is associated with a steep learning curve (LC), necessitating additional attention from surgeons to ensure patient safety and surgical efficacy. The current literature is constrained by the small sample sizes of studies and their observational nature. This systematic review aims to evaluate the literature and identify strengths and weaknesses related to the assessment of EETA-LC.

METHODS: A systematic review was conducted following the PRISMA guidelines. PubMed and Google Scholar were searched for clinical studies on EETA-LC using detailed search strategies, including pertinent keywords and Medical Subject Headings. The selection criteria included studies comparing the outcomes of skull-base surgeries involving pure EETA in the early and late stages of surgeons’ experience, studies that assessed the learning curve of at least one surgical parameter, and articles published in English.

RESULTS: The systematic review identified 34 studies encompassing 5,648 patients published between 2002 and 2022, focusing on the EETA learning curve. Most studies were retrospective cohort designs (88%). Various patient assortment methods were noted, including group-based and case-based analyses. Statistical analyses included descriptive and comparative methods, along with regression analyses and curve modeling techniques. Pituitary adenoma (PA) being the most studied pathology (82%). Among the evaluated variables, improvements in outcomes across variables like EC, OT, postoperative CSF leak, and GTR. Overcoming the initial EETA learning curve was associated with sustained outcome improvements, with a median estimated case requirement of 32, ranging from 9 to 120 cases. These findings underscore the complexity of EETA-LC assessment and the importance of sustained outcome improvement as a marker of proficiency.

CONCLUSIONS: The review highlights the complexity of assessing the learning curve in EETA and underscores the need for standardized reporting and prospective studies to enhance the reliability of findings and guide clinical practice effectively.

PMID:38705991 | DOI:10.1186/s12893-024-02418-y

J Orthop Surg Res. 2024 May 5;19(1):279. doi: 10.1186/s13018-024-04762-4.

ABSTRACT

BACKGROUND: This study aimed to compare the efficacy of intra-articular prolotherapy (IG) combined with peri-articular perineural injection (PG) in the management of knee osteoarthritis (KOA).

METHODS: A total of 60 patients with the diagnosis of KOA were included in this double-blinded randomized controlled clinical trials. The inclusion criteria were as follow: (1) 48-80 years old; (2) the diagnose of KOA; (3) the grade 2 and 3 of the Kellgern-Lawrence grading scale; (4) the pain, crepitation, and knee joint stiffness continuing for 3 months at least. The main exclusion criteria were as follow: (1) any infection involving the knee skin; (2) history of any Influencing factors of disease. All patients were divided into three groups and received either IG, PG and I + PG under the ultrasound guidance and the 2, 4 and 8 weeks follow-up data of patients were available. (IG n = 20 or PG n = 20, I + PG n = 20). Visual Analogue Scale (VAS), The Western Ontario McMaster University Osteoarthritis Index (WOMAC) and the pressure pain threshold (PPT) were used as outcome measures at baseline, 2, 4 and 8 weeks.

RESULTS: There were no statistically significant differences in terms of age, sex, BMI, duration of current condition and baseline assessments of pain intensity, WOMAC scores and PPT. After treatment, the improvement of VAS activity, WOMAC and PPT values was showed compared with pre-treatment in all groups (p < 0.05). At 4 and 8 weeks after treatment, the VAS and WOMAC scores of the I + PG were significantly lower than those of the PG or IG, and the difference was statistically significant (p < 0.05). The PPT values of PG and I + PG were significantly improved compared to IG at 2, 4, and 8 weeks after treatment.

CONCLUSION: The ultrasound guided I + PG of 5% glucose seem to be more effective to alleviate pain and improve knee joint function than single therapy in short term. Clinical rehabilitators could clinically try this combination of I + PG to improve clinical symptoms in patients with KOA.

PMID:38705988 | DOI:10.1186/s13018-024-04762-4

Acta Orthop Traumatol Turc. 2024 Mar 1. doi: 10.5152/j.aott.2024.21091. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of this study was to biomechanically compare a new lateral-pinning technique, in which pins engage the medial and lateral columns of the distal humerus in a divergent configuration in both the axial and sagittal planes instead of the coronal plane, with the cross-pin, and with 2 and 3 coronally divergent lateral-pin techniques in a synthetic humerus model of supracondylar humerus fractures.

METHODS: Thirty-six identical synthetic models of the humerus simulating a standardized supracondylar humerus fracture were included in this study. They were divided into 4 groups based on the pin configuration of fixation: the new 3-lateral pin-fixation technique (group A), 2 crossed pins (group B), 3 divergent lateral pins (group C), and 2 divergent lateral pins (group D). Each model was subjected to combined axial and torsional loading, and then torsional stability and torsional stiffness (Nmm/°) were recorded.

RESULTS: Group A had greater rotational stability than groups C and D but had no statistically significant additional rotational stability compared with group B (P=.042, P=.008, P=.648, respectively), whereas group B had greater rotational stability than only group D (P=.020). Furthermore, group A demonstrated higher internal rotational stiffness compared with groups C and D (P=.038, P=.006, respectively). Group B had better internal rotational stiffness than group D (P=.015). There was no significant difference in internal rotational stiffness between groups A and B (P=. 542), groups B and C (P=.804), and groups D and C (P=.352). Although no statistically significant differences existed between groups A and B, the modified pin configuration exhibited the highest torsional stability and stiffness. Group D showed the lowest values in all biomechanical properties.

CONCLUSION: This study has shown us that this new lateral-pinning technique may provide torsional resistance to internal rotational displacement as strong as the standard technique of crossed-pin configuration of fixation. Furthermore, with this new pin configuration, greater torsional resistance can be obtained than with either the standard 2- or the standard 3-lateral divergent pin configuration. Cite this article as: Bilgili F, Demirel M, Birişik F, Balcı Hİ, Sunbuloglu E, Bozdag E. A new configuration of lateral-pin fixation for pediatric supracondylar humeral fracture: A biomechanical analysis. Acta Orthop Traumatol Turc., 2023 10.5152/j.aott.2024.21091 [Epub Ahead of Print].

PMID:38705973 | DOI:10.5152/j.aott.2024.21091

Biochem Genet. 2024 May 5. doi: 10.1007/s10528-024-10819-0. Online ahead of print.

ABSTRACT

Ovarian cancer is typically diagnosed at an advanced stage, recurs early and often, and currently lacks effective treatment. Therefore, overall survival and progression-free survival are relatively short for this disease. Sensitive and specific biomarkers for early diagnosis and follow-up for effective treatment of the disease are currently lacking. MicroRNA (miRNA/miR) expression studies are widely used in cancer research. Disruption or malfunction of miRNAs, a class of noncoding small RNAs, has been implicated in cancer progression in several publications. Of note, the expression of a series of miRNAs is known to differ in ovarian cancer. In cancer research, it is crucial to analyze expression patterns in both cancer patients and healthy individuals to identify cancer-specific biological markers and to understand their role in cancer. In the present study, the expression levels of miR-3653-3p in the peripheral blood mononuclear cells (PBMCs) of 150 patients with high-risk ovarian cancer were determined, including those with a family history of cancer or an early-age diagnosis of ovarian cancer, as well as 100 healthy individuals. The results were then compared between the two groups. The expression level of miR-3653-3p in the PBMCs of patients with ovarian cancer was determined to be 9.49-fold higher than that in the healthy control group, and this result was statistically significant (P < 0.001). In addition, receiver-operating characteristic curve analysis of PBMC showed statistical significance of miR-3653-3p in discriminating ovarian cancer patients from healthy subjects (P < 0.001). These results suggest that miR-3653-3p detected in peripheral blood may be used as a non-invasive biomarker for ovarian cancer.

PMID:38705961 | DOI:10.1007/s10528-024-10819-0

Med Biol Eng Comput. 2024 May 6. doi: 10.1007/s11517-024-03112-0. Online ahead of print.

ABSTRACT

To address an emerging need for large number of diverse datasets for rigor evaluation of signal processing techniques, we developed and evaluated a new method for generating synthetic electrogastrogram time series. We used electrogastrography (EGG) data from an open database to set model parameters and statistical tests to evaluate synthesized data. Additionally, we illustrated method customization for generating artificial EGG time series alterations caused by the simulator sickness. Proposed data augmentation method generates synthetic EGG data with specified duration, sampling frequency, recording state (postprandial or fasting state), overall noise and breathing artifact injection, and pauses in the gastric rhythm (arrhythmia occurrence) with statistically significant difference between postprandial and fasting states in > 70% cases while not accounting for individual differences. Features obtained from the synthetic EGG signal resembling simulator sickness occurrence displayed expected trends. The code for generation of synthetic EGG time series is not only freely available and can be further customized to assess signal processing algorithms but also may be used to increase data diversity for training artificial intelligence (AI) algorithms. The proposed approach is customized for EGG data synthesis but can be easily utilized for other biosignals with similar nature such as electroencephalogram.

PMID:38705957 | DOI:10.1007/s11517-024-03112-0

J Egypt Natl Canc Inst. 2024 May 6;36(1):14. doi: 10.1186/s43046-024-00218-2.

ABSTRACT

BACKGROUND: Nivolumab (Nivo) and ipilimumab (Ipi) have revolutionized cancer treatment by targeting different pathways. Their combination shows promising results in various cancers, including melanoma, but not all studies have demonstrated significant benefits. A meta-analysis was performed to assess the effectiveness and safety of Nivo-Ipi compared to Nivo alone in advanced cancer types (excluding melanoma).

METHODS: Following PRISMA guidelines, we conducted a meta-analysis up to September 30, 2023, searching databases for randomized controlled trials (RCTs). We focused on advanced solid malignancies (excluding melanoma) with specific Nivo and Ipi dosing. Primary outcomes were overall survival (OS), progression-free survival (PFS), grades 3-4 adverse events (AEs), and treatment-related discontinuations. Secondary outcomes included specific adverse events. Statistical analysis in Review Manager included hazard ratio (HR) and risk ratio (RR), assessing heterogeneity (Higgins I²).

RESULTS: Nine RCTs, involving 2152 patients covering various malignancies, were analyzed. The Nivo plus Ipi group exhibited a median OS of 12.3 months and a median PFS of 3.73 months, compared to monotherapy with 11.67 months and 3.98 months, respectively. OS showed no significant difference between Nivo and Ipi combination and Nivo alone (HR = 0.97, 95% CI: 0.88 to 1.08, p = 0.61). PFS had a slight improvement with combination therapy (HR = 0.91, 95% CI: 0.82 to 1.00, p = 0.04). Treatment-related cumulative grades 3-4 adverse events were higher with Nivo and Ipi (RR = 1.52, 95% CI: 1.30 to 1.78, p < 0.00001), as were treatment-related discontinuations (RR = 1.99, 95% CI: 1.46 to 2.70, p < 0.0001). Hepatotoxicity (RR = 2.42, 95% CI: 1.39 to 4.24, p = 0.002), GI toxicity (RR = 2.84, 95% CI: 1.44 to 5.59, p = 0.002), pneumonitis (RR = 2.29, 95% CI: 1.24 to 2.23, p = 0.008), dermatitis (RR = 2.96, 95% CI: 1.08 to 8.14, p = 0.04), and endocrine dysfunction (RR = 6.22, 95% CI: 2.31 to 16.71, p = 0.0003) were more frequent with Nivo and Ipi.

CONCLUSIONS: Combining nivolumab and ipilimumab did not significantly improve overall survival compared to nivolumab alone in advanced cancers (except melanoma). However, it did show slightly better PFS at the cost of increased toxicity, particularly grades 3-4 adverse events. Specific AEs occurred more frequently in the combination group. Further trials are needed to fully assess this combination in treating advanced cancers.

PMID:38705953 | DOI:10.1186/s43046-024-00218-2

Adv Ther. 2024 May 5. doi: 10.1007/s12325-024-02845-6. Online ahead of print.

ABSTRACT

INTRODUCTION: Spinal muscular atrophy (SMA) is a severe genetic neuromuscular disease characterized by a loss of motor neurons and progressive muscle weakness. Children with untreated type 1 SMA never sit independently and require increasing levels of ventilatory support as the disease progresses. Without intervention, and lacking ventilatory support, death typically occurs before the age of 2 years. There are currently no head-to-head trials comparing available treatments in SMA. Indirect treatment comparisons are therefore needed to provide information on the relative efficacy and safety of SMA treatments for healthcare decision-making.

METHODS: The long-term efficacy and safety of risdiplam versus nusinersen in children with type 1 SMA was evaluated using indirect treatment comparison methodology to adjust for differences between population baseline characteristics, to reduce any potential bias in the comparative analysis. An unanchored matching-adjusted indirect comparison was conducted using risdiplam data from 58 children in FIREFISH (NCT02913482) and published aggregate nusinersen data from 81 children obtained from the ENDEAR (NCT02193074) and SHINE (NCT02594124) clinical trials with at least 36 months of follow-up.

RESULTS: Children with type 1 SMA treated with risdiplam had a 78% reduction in the rate of death, an 81% reduction in the rate of death or permanent ventilation, and a 57% reduction in the rate of serious adverse events compared with children treated with nusinersen. Children treated with risdiplam also had a 45% higher rate of achieving a Hammersmith Infant Neurological Examination, Module 2 motor milestone response and a 186% higher rate of achieving a ≥ 4-point improvement in Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders compared with children treated with nusinersen.

CONCLUSION: Long-term data supported risdiplam as a superior alternative to nusinersen in children with type 1 SMA. Video abstract available for this article. Video abstract (MP4 184542 KB).

PMID:38705943 | DOI:10.1007/s12325-024-02845-6