Tag: pubmed

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

Pharmaceut Med. 2024 May 6. doi: 10.1007/s40290-024-00524-z. Online ahead of print.

ABSTRACT

INTRODUCTION: Spontaneous reporting of adverse events (AEs) is a mainstay of pharmacovigilance, and an ongoing challenge is how to ensure that more high-quality reports are collected for comprehensive information provision. The Med Safety App, a smartphone-based application, was launched in Nigeria in November 2020 to provide an electronic platform for users to seamlessly report AEs. There has been a paucity of evidence on the use of this application or other mobile applications for reporting adverse drug reactions/AEs following immunization in the Nigerian environment.

OBJECTIVE: The aim of this study was to evaluate the trends in adverse event reporting before and after the introduction of the Med Safety App in Nigeria.

METHODS: This was a retrospective, observational study using data from the VigiFlow database to compare adverse event reporting in Nigeria before and after the deployment of the Med Safety App. The baseline period was 1st April 2019 to 30th October 2020 and the comparison period was 1st November 2020 to 31st May 2022. We used Vigilance Hub, the back-end system for the Med Safety App, to extract data on App downloads and de-identified user statistics. Data were summarized using descriptive statistics, frequencies and proportions. Quality was assessed by assigning a completeness score to each individual case safety report. The Kruskal-Wallis test was used to test for differences in medians between groups.

RESULTS: Following deployment of the App, the Nigerian National Pharmacovigilance Centre recorded an increase in the total number of adverse event reports received in VigiFlow, from 2051 in the baseline period to 18,995 following deployment of the App, with 81.7% of those reported via the Med Safety App. There was a reduction in the proportion of paper-based reporting from 98.4 to 15.7% post-deployment, and direct reporting by consumers increased from 2.7 to 17.6%. Of the 15,526 reports submitted via the App, 15,111 (97.3%) had a completeness score above 70% and 6993 (45%) had a completeness score of 100%. The median completeness score of adverse event reports on the Med Safety App was 6 out of 7. On bivariate analysis using the Kruskal-Wallis test, there was an association between means of reporting and completeness score, and this association was significant, with a p value of 0.0001, which may reflect the validation rules that are applied within the App.

CONCLUSION: Deployment of the Med Safety App increased both the number and quality of adverse event reports; however, more awareness and capacity building are needed to strengthen and sustain reporting on the tool by all categories of healthcare professionals and consumers/patients.

PMID:38705932 | DOI:10.1007/s40290-024-00524-z

J Egypt Public Health Assoc. 2024 May 6;99(1):9. doi: 10.1186/s42506-024-00155-x.

ABSTRACT

BACKGROUND: Earth’s climate changes are progressing at an alarming rate. One of the most severe effects of climate change is extreme heat. This study aimed to assess knowledge and adaptation behavior to heat-related illness (HRI) among solid waste disposal workers in the 10th of Ramadan City, Egypt, and to study the predictors for their knowledge and adaptation behavior.

METHODS: An exploratory cross-sectional study was conducted on 220 solid waste disposal workers. A structured interview questionnaire was used to assess the studied workers’ sociodemographic and occupational characteristics, heat exposure risk, and their knowledge, and adaptation behavior.

RESULTS: The results showed that 40% and 30% of participants had adequate levels of total knowledge and adaptation behavior, respectively. There was a statistically significant relationship between workers’ knowledge and both age and education. There was a statistically significant relationship between workers’ adaptation behavior and age, duration of employment, working hours, and education. A binary logistic regression for significant predictors of knowledge and adaptation behavior showed that age and education were the most significant predictors.

CONCLUSION: Solid waste disposal workers were at high risk of HRI due to their low levels of knowledge and adaptation behavior regarding HRI. Educational health programs that guide workers to follow healthy behaviors and prevent HRI are recommended.

PMID:38705924 | DOI:10.1186/s42506-024-00155-x

J Anim Physiol Anim Nutr (Berl). 2024 May 5. doi: 10.1111/jpn.13977. Online ahead of print.

ABSTRACT

Slow feeding devices (SFDs) are useful tools in order to improve the horse well-being and to reduce wastage, but their use may result in unnatural posture during feeding and frustration behaviours. Moreover, it may be important to evaluate the laterality during feeding. The aim of the study was to investigate ponies’ feeding behaviour (i.e., lateralisation, frustration, postural eating style) with different hay feeding methods: on the ground (G), a fully filled hay net (HF), a partially filled hay net (HL), and a slow feeder hay box (HB). Nine ponies of two different breed types (Shetland and Welsh/Cob) were evaluated. Video recordings were obtained and then behavioural analysis was conducted. Data were analysed statistically using k-means cluster analysis, repeated measurement mixed model procedure, principal component analysis (PCA) and Pearson’s correlation coefficient. Head tilting was more often performed during feeding from HF and HL compared to G and HB. Forelimb forward, referring to the position that ponies assumed during feeding, was performed less frequently with the hay nets. Ponies, in particular Welsh/Cobs, tended to be more left-lateralized and performed more backward ears when feeding from the hay nets. Blink rate was observed to be greater when ponies were fed from G. No head pushing, striking with forelimb and pawing while feeding was seen. Animals fed from HF tended to eat from the top of the hay net and consequently showed an arched neck; while HL and HB showed for elongated neck an intermediate pattern between G and HF. From our results, HB seemed to be a useful compromise between natural feeding on the ground and the use of hay nets.

PMID:38704815 | DOI:10.1111/jpn.13977