Category: Statistics

Trials. 2025 Sep 16;26(1):341. doi: 10.1186/s13063-025-08995-4.

ABSTRACT

BACKGROUND: Morbidity due to anastomotic leakage is a major concern in transthoracic oesophagectomy. The aim of this randomised trial is to evaluate whether a circumferential suture reinforcement of the stapled end-to-side anastomosis in robot-assisted minimally invasive Ivor-Lewis oesophagectomy (RAMIE) leads to a reduced incidence of anastomotic leakages in the postoperative course.

METHODS/DESIGN: This is a multi-centre randomised, double-blind, superiority trial with an adaptive sample size design undergoing RAMIE for malignant tumours. Patients will be randomised 1:1 into two study arms. In study arm A, participants will receive a standard circular-stapled end-to-side oesophagogastric anastomosis, while in study arm B, the anastomosis will have a circumferential suture reinforcement. The primary endpoint is the rate of anastomotic leakage. Secondary endpoints are incision-to-suture time, duration of circumferential suture reinforcement, anastomotic stenosis rate, postoperative morbidity and mortality, and quality of life.

DISCUSSION: This randomised controlled trial will assess the impact of circumferential suture reinforcement of the oesophagogastric anastomosis on short-term outcomes and quality of life of patients undergoing robot-assisted minimally invasive Ivor-Lewis oesophagectomy.

TRIAL REGSITRATION: DRKS00034787. Registered on 7 October 2024.

PMID:40958134 | DOI:10.1186/s13063-025-08995-4

Eur J Sport Sci. 2025 Oct;25(10):e70038. doi: 10.1002/ejsc.70038.

ABSTRACT

This study investigated the associations between ovarian hormones, symptoms, sleep characteristics and nocturnal physiology in female athletes. Twenty-four National Rugby League Indigenous Women’s Academy athletes (naturally cycling: n = 11 and mean age: 21 ± 3 years; hormonal contraception: n = 13 and mean age: 22 ± 3 years) completed a 5-week training camp. During the camp, oestradiol and progesterone concentrations were analysed at three timepoints according to naturally cycling and hormonal contraception groups. Symptoms and subjective sleep were measured daily. Athletes were instructed to wear an Oura ring throughout the camp for sleep and nocturnal heart rate (HR) and HR variability (HRV) measures. Statistical analyses included linear mixed models and Pearson’s correlations. Neither objective (Oura ring) nor subjective (survey) sleep characteristics were associated with oestradiol or progesterone concentrations. In the naturally cycling group, a higher number of total symptoms were associated with a longer sleep onset latency (r = 0.88, 95% CI [0.60, 0.97]) and increased light sleep (r = 0.75, 95% CI [0.28, 0.93]). Higher oestradiol concentrations were significantly associated with fewer symptoms (estimate ± SE: -0.007 ± 0.002 symptoms, p = 0.003). Luteal days were associated with higher average nocturnal HR and lower HRV than follicular menstrual cycle days (estimate ± SE: 4 ± 0.57 bpm, p < 0.001; estimate ± SE: -7 ± 2.13 ms, p < 0.001, respectively). Negligible to moderate correlations were observed between sleep and total symptoms experienced by athletes using hormonal contraception. In conclusion, sleep measures were not significantly associated with ovarian hormone concentrations. A higher number of total symptoms were associated with sleep disturbance in naturally cycling athletes. To optimise sleep, female athletes may benefit from monitoring and managing menstrual cycle symptoms.

PMID:40958133 | DOI:10.1002/ejsc.70038

Knee Surg Relat Res. 2025 Sep 16;37(1):38. doi: 10.1186/s43019-025-00290-5.

ABSTRACT

BACKGROUND: Implant design in total knee arthroplasty (TKA) has evolved considerably, with recent developments focusing on reproducing native knee kinematics. Some implants now feature anatomically and physiologically accurate articular surface geometries. This study aimed to evaluate the impact of different implant designs on knee kinematics using the same cadaveric specimens to ensure consistent comparison. We hypothesized that implant designs incorporating features intended to replicate native joint anatomy, such as the kinematic retaining (KR) design, would more closely reproduce physiological knee kinematics.

METHODS: TKA was performed on nine Thiel-embalmed cadaveric knees with mild medial osteoarthritis, using three implant designs from the Physica system: KR, cruciate retaining (CR), and medial congruent (MC) designs. All procedures were performed using a mechanical alignment technique, with both the posterior tibial slope and femoral rotational angle standardized at 3°. The posterior cruciate ligament was preserved throughout the evaluation of all implant designs. A navigation system was used to collect detailed kinematic data. Evaluations were conducted after trial component placement, focusing on anteroposterior, mediolateral, and compression-distraction positions, as well as rotational angles. From these knee status data, femoral rotational kinematics relative to the tibia and the anteroposterior translation of both femoral condyles during flexion were also calculated.

RESULTS: No significant differences in flexion and extension angles were observed between the groups. The KR group presented the greatest mean femoral external rotation relative to the tibia throughout the range of motion among the groups; however, there were no statistically significant differences. The CR and MC group showed significantly reduced anteroposterior translation of the lateral condyle compared with the native knee (p = 0.021 and 0.003, respectively). Furthermore, the anteroposterior translation of the lateral femoral condyle was significantly greater in the KR group than in MC groups (p = 0.021). In the KR group, six of nine knees exhibited medial pivot motion, compared with three in the CR group and four in the MC group.

CONCLUSIONS: Using identical cadaveric specimens and navigation-based analysis, we identified distinct kinematic profiles associated with each implant design. Notably, the KR implant demonstrated kinematics approximating native knee motion; however, these findings remain preliminary and warrant further clinical validation.

LEVEL OF EVIDENCE: III.

PMID:40958131 | DOI:10.1186/s43019-025-00290-5

BMC Sports Sci Med Rehabil. 2025 Sep 16;17(1):265. doi: 10.1186/s13102-025-01307-y.

ABSTRACT

BACKGROUND: Cardiovascular disease and obesity-related comorbidities are key factors addressed by metabolic-bariatric surgery (MBS). Although High intensity interval training (HIIT) has been proven effective in healthy cohorts, limited evidence exists regarding HIIT and adherence towards HIIT after MBS. This study aims to test feasibility and cardiorespiratory effect of HIIT after MBS.

METHODS: 201 patients undergoing MBS were included in a four-week training protocol with 3 training groups (B-D) including different HIIT protocols on a bicycle designed for patients with obesity and one control group (A) at a university medical center in Germany. Ergometry with estimated VO2max, maximum blood lactate, maximum resistance, time spent on ergometer, and heart rate were performed prior to and after 4 weeks of training.

RESULTS: A significant effect of the four-week training could be shown through reduction of heart rate at 100 W, increase of maximum blood lactate, and maximum resistance when comparing the training groups to the control group (Δ 9,67 BPM; Δ 1.02 mmol/l; Δ 12 W respectively, all p < 0.05) However, adherence of the recruited patient group was very low, shown by a notably high drop-out rate of 78.1% overall (44 patients completed training). The majority of patients dropped out prior to the first training session.

CONCLUSIONS: HIIT bicycle training in post-MBS patients is possibly very effective, however, adherence is extremely low. Although this study shows promising results, an effect on large patient groups cannot be expected if improvement of adherence and a wide range of training methods are not addressed first.

STUDY REGISTRATION: German Registry for Clinical Trials (DRKS) trial registration number DRKS00024939 on 20/09/2021.

PMID:40958128 | DOI:10.1186/s13102-025-01307-y

Crit Care. 2025 Sep 16;29(1):396. doi: 10.1186/s13054-025-05645-8.

NO ABSTRACT

PMID:40958116 | DOI:10.1186/s13054-025-05645-8

BMC Infect Dis. 2025 Sep 16;25(1):1110. doi: 10.1186/s12879-025-11521-1.

ABSTRACT

BACKGROUND: Acute respiratory infections (ARI) exhibit varying lethality rates, influenced by individual and population factors. This retrospective study aimed to analyse infection frequency, clinical characteristics, and factors associated with lethality in hospitalized patients with seasonal ARI pathogens.

METHODS: Virological and demographic data of hospitalized patients ≥ 18 years who tested positive for at least one ARI viral pathogen (Influenza, Adenovirus, Coronavirus, human Metapneumovirus (hMPV), Parainfluenza, Rhinovirus, Respiratory Syncytial Virus (RSV) and SARS-CoV-2) were collected from 07/2022 to 04/2023 at a German tertiary care hospital. Logistic regression analysis was used to analyse factors influencing lethality. Univariate comparisons examined pathogen-specific differences in length of stay and lethality.

RESULTS: Among 1,657 hospitalized patients with at least one detected ARI pathogen, 89 (5.5%) passed away. Logistic regression analysis indicated a significant association between advanced age and lethality (OR = 1.05 per year, p < 0.0001). Patients infected with ARI pathogens other than SARS-CoV-2 or hMPV exhibited a heightened risk of lethality compared to those with Influenza. While statistical significance was reached only for Adenovirus (OR = 5.99, p = 0.049), elevated risk of lethality was also observed among hospitalized patients infected with Coronavirus (OR = 2.22), RSV (OR = 2.18), and more than one pathogen (OR = 2.07).

CONCLUSIONS: Lethality rates varied among the examined ARI pathogens. Compared to Influenza, Adenovirus, Coronavirus, and RSV showed elevated lethality rates and an increased risk of intrahospital death among ARI-infected patients. RSV emerged as a notable concern for hospitalized adults. Additionally, age also arises as a significant risk factor for lethality associated with ARI during hospitalization.

TRIAL REGISTRATION: This study is a retrospective analysis of fully anonymized routinely collected patient data and does not require registration in a clinical trial registry.

PMID:40958111 | DOI:10.1186/s12879-025-11521-1

BMC Oral Health. 2025 Sep 16;25(1):1408. doi: 10.1186/s12903-025-06782-w.

ABSTRACT

OBJECTIVE: This study aimed to correlate the dimensions of the maxillary sinus in CBCT-reformatted panoramic radiographs to the greater palatine canal geometry and its neighbor structures in CBCT multiplanar images, so considering the limitations of the current study, we could use panoramic radiographs as an alert tool before performing a variety of implant surgical and dental procedures concerning the Greater Palatine Canal (GPC).

METHODS: The GPC pathway and its neighbor structures were assessed in a sample of 48 CBCT Egyptian adult patients’ images (24 females and 24 males) in the three orthogonal planes and correlated to the height, width and hypothetical surface area of the maxillary sinus (MS).

RESULTS: There was a statistically significant difference in sagittal planes among genders regarding GPC pathway, as Type a was the most prominent GPC pathway among females (an antero-inferior direction) in contrast to male cases that shown Type c (posterior-inferior direction, then an anterior-inferior direction) pathway. Male patients had significantly lower GPC angle than female patients (P = 0.022). Males had greater mean values of MS height, width & hypothetical surface area than females. The greater the GPC angle in sagittal plan, the lesser MS height, width & hypothetical surface area. In addition, MS of greater height had more posterior extension (depth).

CONCLUSION: Considering the restrictions of the current retrospective study, the current study illustrated a significant correlation between maxillary sinus (MS) dimensions and greater palatine canal (GPC) anatomy, specifically the GPC pathway and angle. Larger MS (especially height) correlated with GPC with more posterior pathway and lesser angle, which is sex-based association. These findings are with great clinical significance to minimize the risk of GPC neurovascular bundle iatrogenic injury during interventions dealing with posterior maxilla, particularly sinus lifts, implant planning, due to potential impingement from MS expansion.

PMID:40958094 | DOI:10.1186/s12903-025-06782-w

ACS Appl Mater Interfaces. 2025 Sep 16. doi: 10.1021/acsami.4c20938. Online ahead of print.

ABSTRACT

An alternative method for fabricating planar surface-enhanced Raman spectroscopy (SERS) sensors, offering enhanced performance compared to conventional drop-casting techniques, is presented. We synthesized stable gold nanoparticles (AuNPs) with an average diameter of 16 ± 2 nm and developed two types of SERS sensors using pyro-electrohydrodynamic jet printing (p-jet) technology. The first sensor, printed on a glass substrate, featured a corona pattern with sensing areas aligned to the laser spot size, enabling efficient sampling with minimal material waste. The second sensor, fabricated on a dithiol-functionalized gold substrate, demonstrated uniform nanoparticle coverage. SERS activity was evaluated using p-Mercaptoaniline (pMA), yielding intense and reproducible spectra. Raman imaging confirmed consistent SERS activity, uniform nanoparticle distribution, and sensor stability. Statistical analysis indicated high reproducibility in sensor dimensions and shapes, underscoring the potential of p-jet microprinting as a cost-effective, stable, and scalable method for producing high-performance SERS sensors suitable for diverse applications.

PMID:40958078 | DOI:10.1021/acsami.4c20938

Anaesthesiologie. 2025 Sep 16. doi: 10.1007/s00101-025-01592-9. Online ahead of print.

ABSTRACT

BACKGROUND: The response time (“Hilfsfrist”) in Germany is an important planning parameter that determines the arrival times of emergency medical services and is regulated by state legislation. This study analyzes arrival times in the German federal states.

MATERIAL AND METHOD: The German Resuscitation Registry uniformly records arrival times for the first vehicle on the scene and the complete team (team arrival time: ambulance and emergency physician) nationwide. The statistical testing of the null hypothesis, equality between the federal states, was conducted using the Kruskal-Wallis test. Binary logistic regression analyses were used to examine the impact of arrival times on survival rates.

RESULTS: The null hypothesis had to be rejected (p < 0.001), indicating that arrival times differ between the federal states (first vehicle: mean arrival times ranged from 5.7 ± 2.6 min to 7.4 ± 3.5 min; 90th percentile: 9-13 min; team arrival time ranged from 8.6 ± 3.6 min to 11.9 ± 5.9 min; 90th percentile: 13-21 min; 2014-2024: n = 104,657; 201 ambulance services). In 10 out of 16 federal states, fewer than 80% of patients were reached by the first vehicle within 8 min. The regression analyses showed that longer arrival and team arrival times were negatively associated with good neurological recovery at discharge (team arrival time ≥ 12 min: odds ratio, OR =0.54, confidence interval, CI =0.39-0.75, p < 0.001; n = 45,873; 71 reference emergency medical services, EMS, sites).

CONCLUSION: Patients receive qualitatively different levels of care across the federal states due to variations in arrival times. Shorter arrival times are associated with better chances of survival. Equal quality of care is a constitutional requirement by the German constitution but it is not being achieved.

PMID:40958064 | DOI:10.1007/s00101-025-01592-9

J Neurooncol. 2025 Sep 16. doi: 10.1007/s11060-025-05186-8. Online ahead of print.

ABSTRACT

PURPOSE: Predicting future tumor growth from initial imaging of incidentally discovered meningioma (IDM) could inform treatment decisions. However, most factors identified in prior studies on meningioma growth are qualitative. The aim of this study is to identify factors associated with tumor growth using quantitative radiomics features from MRI data.

METHODS: MRI T2 features from initial imaging of 24 tumor growth cases were compared with those of 25 cases without growth. An in-house program was developed to reduce the time required for data analysis. This program is based on the open-source software 3D Slicer 5.6.2 and PyRadiomics 3.1.0. It enables semi-automatic batch t-test analyses for each feature to compare tumor growth and non-growth groups. Regions of interest (ROIs) were placed in the tumor, outer tumor edge, whole brain, and white matter contralateral to the tumor. A total of 107 features were analyzed across seven classifications: First Order, Shape, Gray Level Co-occurrence Matrix, Gray Level Run Length Matrix, Gray Level Size Zone Matrix, Gray Level Dependence Matrix, and Neighboring Gray Tone Difference Matrix. A t-test was used to identify significant predictors.

RESULTS: Ten features across five classifications showed significant differences (p < 0.05): 2 First Order statistics, 2 Shape features, 4 Gy Level Co-occurrence Matrices, 1 Gy Level Size Zone Matrix, and 1 Neighboring Gray Tone Difference Matrix.

CONCLUSIONS: Potential predictors of IDM growth were identified using radiomics features. Future studies with larger cohorts and validation will be essential to confirm the clinical utility and improve the predictive accuracy of these features.

PMID:40958042 | DOI:10.1007/s11060-025-05186-8