Clinical Reference Research Articles

Solid-state esophageal pressure sensor for the estimation of pleural pressure: a bench and first-in-human validation study

BackgroundAdvanced respiratory monitoring through the measurement of esophageal pressure (Pes) as a surrogate of pleural pressure helps guiding mechanical ventilation in ICU patients. Pes measurement with an esophageal balloon catheter, the current clinical reference standard, needs complex calibrations and a multitude of factors influence its reliability. Solid-state pressure sensors might be able to overcome these limitations.ObjectivesTo evaluate the accuracy of a new solid-state Pes transducer (Pessolid). We hypothesized that measurements are non-inferior to those obtained with a properly calibrated balloon catheter (Pesbal).MethodsAbsolute and relative solid-state sensor Pes measurements were compared to a reference pressure in a 5-day bench setup, and to simultaneously placed balloon catheters in 15 spontaneously breathing healthy volunteers and in 16 mechanically ventilated ICU patients. Bland–Altman analysis was performed using mixed effects modelling with bootstrapping to estimate bias and upper and lower limits of agreement (LoA) and their confidence intervals.ResultsBench study: Solid-state pressure transducers had a positive bias (Psolid – Pref) of around 1 cmH2O for the absolute minimal and maximum pressures, and no bias for pressure swings. Healthy volunteers: the solid-state transducer revealed a bias (i.e., Pessolid – Pesbal) [upper LoA; lower LoA] of 1.59 [8.21; − 5.02], − 2.32 [4.27; − 8.92] and 3.91 [11.04; − 3.23] cmH2O for end-expiratory, end-inspiratory and ΔPes values, respectively. ICU patients: the solid-state transducer showed a bias (Pessolid–Pesbal) [upper LoA; lower LoA] during controlled/assisted ventilation of: − 0.15 [1.41; − 1.72]/− 0.19 [5.23; − 5.62], 0.32 [3.45; − 2.82]/− 0.54 [4.81; − 5.90] and 0.47 [3.90; − 2.96]/0.35 [4.01; − 3.31] cmH2O for end-expiratory, end-inspiratory and ΔPes values, respectively. LoA were ≤ 2cmH2O for static measurements on controlled ventilation.ConclusionsThe novel solid-state pressure transducer showed good accuracy on the bench, in healthy volunteers and in ventilated ICU-patients. This could contribute to the implementation of Pes as advanced respiratory monitoring technique.Trial registrationClinicaltrials.gov identifier: NCT05817968 (patient study). Registered on 18 April 2023.

Mimicking aneurysm in a patient with chronic occlusion of the left middle cerebral artery

The chronic occlusion of intracranial arteries generally has no or mild clinical symptoms, and the clinical symptoms of acute cerebral artery occlusion are mostly manifested as severe cerebral infarction symptoms, which often make early diagnosis difficult, thus losing the best treatment opportunity. Once cerebral infarction occurs, the consequences are difficult to recover. This is also an important reason for the high misdiagnosis rate and mortality of this disease. In this paper, the characteristics of the disease were analyzed to provide clinical reference.

Neural Activity for Uninvolved Knee Motor Control After ACL Reconstruction Differs from Healthy Controls

Recovery from anterior cruciate ligament reconstruction (ACLR) induces bilateral functional and physiological adaptations. Neurophysiologic measures of motor control have focused on the involved knee joint, limiting understanding regarding the extent of bilateral neural adaptations. Therefore, the aim of this study was to investigate differences in neural activity during uninvolved-limb motor control after ACLR compared to healthy controls. Methods: Fifteen participants with left ACLR (8 female and 7 male, 21.53 ± 2.7 years, 173.22 ± 10.0 cm, 72.15 ± 16.1 kg, Tegner 7.40 ± 1.1, 43.33 ± 33.1 mo. post-surgery, 2 patellar tendon, and 13 hamstring) and 15 matched controls (8 female, 23.33 ± 2.7 years, 174.92 ± 9.7 cm, 72.14 ± 15.4 kg, Tegner 7.33 ± 1.0) participated. Neural activity was evaluated using functional magnetic resonance imaging on a 3T Siemens Magnetom scanner during four 30-s cycles of a right (uninvolved) knee flexion-extension task paced with a metronome (1.2 Hz) and was completed interspersed with 30 s of rest. A significance threshold of p < 0.05 was used for all analyses, cluster corrected for multiple comparisons, and z-thresholds of >3.1 (subject level), and >2.3 (group level). Results: The ACLR group had greater neural activity in one statistically significant cluster corresponding to the left middle frontal gyrus (MFG) (834 voxels, z = 3.81, p < 0.01 multiple comparisons corrected) compared to controls. Conclusions: These data indicate a potential contribution to uninvolved-knee neuromuscular deficits after injury and support the limitations of using the uninvolved side as a clinical reference. Uninvolved knee motor control after ACLR may require greater cognitive demand. Clinicians should be aware that the uninvolved limb might also demonstrate whole brain alterations limiting clinical inference from functional symmetry.

Evaluation of antimicrobial susceptibility testing methods for Burkholderia cepacia complex isolates from people with and without cystic fibrosis.

The Burkholderia cepacia complex (BCC) is a group of Gram-negative bacteria that cause opportunistic infections, most notably in people with cystic fibrosis (CF), and have been associated with outbreaks caused by contaminated medical products. Antimicrobial susceptibility testing (AST) is often used to guide treatment for BCC infections, perhaps most importantly in people with CF who are being considered for lung transplant. However, recent studies have highlighted problems with AST methods. Here, we address limitations from previous studies to further evaluate BCC AST methods. We assessed the performance of reference broth microdilution (BMD), disk diffusion (DD) using Mueller-Hinton agar (MHA) from three manufacturers, agar dilution (AD), and gradient diffusion (ETEST) for ceftazidime (CAZ), levofloxacin (LVX), meropenem (MEM), minocycline (MIN), and trimethoprim-sulfamethoxazole (TMP-SMX) on a set of 205 BCC isolates. The isolate set included 100 isolates from people with CF and 105 isolates from people without CF from a variety of sources, which enabled us to systematically evaluate whether specimen source impacts AST performance. For all BCC isolates, BMD reproducibility was 93%, 98%, 99%, 98%, and 96% for CAZ, LVX, MEM, MIN, and TMP-SMX, respectively. Using BMD as the comparator method, we show that DD, AD, and ETEST perform poorly, with neither MHA manufacturer nor specimen source significantly impacting method performance. Based on our data, we recommend that routine AST should not be performed for BCC isolates. If a provider requests AST, clinical microbiology laboratories should perform Clinical and Laboratory Standards Institute reference methodology for BMD (stored frozen) and report MIC only.IMPORTANCEAntimicrobial susceptibility testing for the Burkholderia cepacia complex (BCC) is often used to determine eligibility for lung transplant in people with cystic fibrosis. However, problems with method performance have been reported. Here, we systematically evaluate the performance of reference broth microdilution, disk diffusion, agar dilution, and gradient diffusion (ETEST) for BCC organisms isolated from people with and without cystic fibrosis. We show that broth microdilution reproducibility is acceptable for levofloxacin, meropenem, minocycline, and trimethoprim-sulfamethoxazole, while ceftazidime was just below the acceptability cut-off. Regardless of specimen source, the results from disk diffusion, agar dilution, and ETEST do not correlate with broth microdilution. Based on these findings, we recommend that antimicrobial susceptibility testing should not be routinely performed for BCC, and if requested by the provider, only broth microdilution following Clinical and Laboratory Standards Institute guidelines should be used. Providers should be aware of the significant limitations of antimicrobial susceptibility testing methods for BCC.

P0689 A clinical study on the optimization of vedolizumab induction therapy for moderate to severe active Ulcerative Colitis at week 10

Abstract Background To observe the clinical efficacy of adding one dose of vedolizumab induction therapy in the 10th week for the treatment of moderate to severe active Ulcerative Colitis (UC), evaluate its effectiveness and safety, and provide clinical reference for the treatment plan of UC patients. Methods This study included a total of 80 UC patients who sought medical treatment at the Department of Gastroenterology at Shengjing Hospital of China Medical University from January 2020 to January 2025. They were divided into two groups: the experimental group (31 cases) received treatment with vedolizumab at weeks 0, 2, 6, 10, and 14, while the control group (49 cases) received treatment with vedolizumab at weeks 0, 2, 6, and 14 for at least 14 weeks. The changes in indicators such as modified Mayo score, Mayo endoscopic score, C-reactive protein (CRP), and safety analysis were observed before and after treatment in both groups. Clinical remission rate, clinical response rate, endoscopic remission rate, and endoscopic response rate were compared. Results The clinical response rate of the experimental group was 100%, significantly higher than the control group’s 84.62% (P<0.05). The endoscopic response rate of the experimental group was 85.71%, significantly higher than the control group’s 57.50% (P<0.05). There was no significant difference between the experimental group and the control group in terms of clinical remission rate and endoscopic remission rate (P>0.05). The CRP levels before and after treatment were significantly reduced between the two groups (P<0.05), and there was no significant difference in the number of patients with normal CRP levels between the groups (P>0.05). Conclusion Adding vedolizumab induction once in week 10 can significantly improve clinical and endoscopic response rates, but more research is needed in terms of clinical and endoscopic response rates.

Brigatinib treatment in a patient with advanced NSCLC with XPO1-ALK fusion: a case report

Patients with ALK-rearranged non-small cell lung cancer (NSCLC) who are treated with ALK tyrosine kinase inhibitors (ALK TKIs) have better prognoses. In this case report, we provide evidence of a novel ALK fusion, XPO1-ALK (intergenic), identified by next-generation DNA sequencing in a patient with advanced lung cancer. After 5 months of brigatinib targeted therapy, the patient clearly experienced tumor disintegration, and this treatment resulted in partial remission. To date, this patient has experienced 5 months of progression-free survival after brigatinib treatment. In addition to reporting the identification of a novel ALK fusion, XPO1-ALK (intergenic), and the sensitivity and safety of brigatinib treatment for lung cancer, this study increased the list of known ALK fusion partners in ALK-positive NSCLC. This case report has a significant clinical reference.

Colorimetric analysis of intraoral scans: A novel approach for detecting gingival inflammation.

Gingivitis, a widely prevalent oral health condition, affects up to 80% of the population. Traditional assessment methods for gingivitis rely heavily on subjective clinical evaluation. This study seeks to explore the efficacy of interpreting the color metrics from intraoral scans to objectively differentiate between healthy and inflamed gingiva. This study used the percentage of bleeding on probing (BOP%) as the clinical reference standard. Intraoral scans, obtained before and after gingivitis treatment using a scanner, were analyzed through a custom MATLAB script to quantify HSV (hue, saturation, value) and CIELAB (Commission Internationale de l'Eclairage L*a*b*) color coordinates. The region of interest was a 2-mm-wide gingival strip along the buccal margin of the maxillary anterior teeth. Linear regression analysis was performed to evaluate the relationship between photometric outcomes and continuous, dichotomous, and categorical BOP data. Diagnostic accuracy was assessed using the area under the receiver operating characteristic (ROC) curve (AUC), as well as sensitivity and specificity measures. The analysis included clinical and digital color data from 110 scans, adhering to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines. The multilevel linear regression analysis underscored a significant correlation between the BOP% and digital color metrics, specifically the CIELAB a* (red-green chroma), CIELAB b* (yellow-blue chroma), and color saturation, with AUC performances of 70%, 79.5%, and 80.8%, respectively. Digital color analysis of intraoral scans has demonstrated a range of performance from acceptable to excellent in distinguishing sites with BOP. This innovative approach presents a promising tool for dentists and researchers in the accurate diagnosis, screening, and management of gingivitis. Our study focuses on finding a better way to detect gingivitis, a common gum disease affecting many people. Traditional methods rely on the dentist's visual inspection, which can be subjective. We explored the use of color measurements from digital intraoral scans to objectively identify healthy versus inflamed gums. We analyzed 110 scans from 55 participants, examining the color differences in the gums before and after treatment. By measuring specific color values, we achieved up to 80.8% accuracy in distinguishing between healthy and inflamed gums. This method could offer a more reliable tool for dentists and researchers to diagnose and manage gingivitis, leading to better oral health outcomes.

Advances in the estimation of body fat percentage using an artificial intelligence 2D-photo method

There is a growing need to evaluate the agreement between the field methods and integrate artificial intelligence (AI) using two-dimensional (2D) photos for enhanced real-world analysis. This study evaluated the agreement between AI-2D photos and the clinical reference method, dual-energy X-ray absorptiometry (DXA) to estimate the body fat percentage (BFP). Other methods were also investigated, including skinfolds, A-mode ultrasound, and bioelectrical impedance analysis (BIA). This cross-sectional study was conducted on 1273 adults of both sexes. The Bland–Altman plots, Lin’s Correlation Coefficient of Agreement (CCC), and error analyses were calculated. AI-2D photos demonstrated substantial agreement with DXA presenting the highest agreement (CCC ≥ 0.96) among all the investigated methods. InBody-270 and Omron HBF-514 BIA devices showed moderate agreement (CCC = 0.90 to 0.95) for all participants, age groups >30 years, and body mass index >25 kg/m2. AI-2D photos can be interchangeable with DXA, providing a practical, accessible alternative and an easy-to-use system for BFP estimation.

Differentiation of Early Sacroiliitis Using Machine-Learning- Supported Texture Analysis.

Objectives: We wished to compare the diagnostic performance of texture analysis (TA) against that of a visual qualitative assessment in identifying early sacroiliitis (nr-axSpA). Methods: A total of 92 participants were retrospectively included at our university hospital institution, comprising 30 controls and 62 patients with axSpA, including 32 with nr-axSpA and 30 with r-axSpA, who underwent MR examination of the sacroiliac joints. MRI at 3T of the lumbar spine and the sacroiliac joint was performed using oblique T1-weighted (W), fluid-sensitive, fat-saturated (Fs) T2WI images. The modified New York criteria for AS were used. Patients were classified into the nr-axSpA group if their digital radiography (DR) and/or CT results within 7 days from the MR examination showed a DR and/or CT grade < 2 for the bilateral sacroiliac joints or a DR and/or CT grade < 3 for the unilateral sacroiliac joint. Patients were classified into the r-axSpA group if their DR and/or CT grade was 2 to 3 for the bilateral sacroiliac joints or their DR and/or CT grade was 3 for the unilateral sacroiliac joint. Patients were considered to have a confirmed diagnosis if their DR or CT grade was 4 for the sacroiliac joints and were thereby excluded. A control group of healthy individuals matched in terms of age and sex to the patients was included in this study. First, two readers independently qualitatively scored the oblique coronal T1WI and FsT2WI non-enhanced sacroiliac joint images. The diagnostic efficacies of the two readers were judged and compared using an assigned Likert score, conducting a Kappa consistency test of the diagnostic results between two readers. Texture analysis models (the T1WI-TA model and the FsT2WI-TA model) were constructed through feature extraction and feature screening. The qualitative and quantitative results were evaluated for their diagnostic performance and compared against a clinical reference standard. Results: The qualitative scores of the two readers could significantly distinguish between the healthy controls and the nr-axSpA group and the nr-axSpA and r-axSpA groups (both p < 0.05). Both TA models could significantly distinguish between the healthy controls and the nr-axSpA group and the nr-axSpA group and the r-axSpA group (both p < 0.05). There was no significant difference in the differential diagnoses of the two TA models between the healthy controls and the nr-axSpA group (AUC: 0.934 vs. 0.976; p = 0.1838) and between the nr-axSpA and r-axSpA groups (AUC: 0.917 vs. 0.848; p = 0.2592). In terms of distinguishing between the healthy control and nr-axSpA groups, both the TA models were superior to the qualitative scores of the two readers (all p < 0.05). In terms of distinguishing between the nr-axSpA and r-axSpA groups, the T1WI-TA model was superior to the qualitative scores of the two readers (p = 0.023 and p = 0.007), whereas there was no significant difference between the fsT2WI-TA model and the qualitative scores of the two readers (p = 0.134 and p = 0.065). Conclusions: Based on MR imaging, the T1WI-TA and fsT2WI-TA models were highly effective for the early diagnosis of sacroiliac joint arthritis. The T1WI-TA model significantly improved the early diagnostic efficacy for sacroiliac arthritis compared to that of the qualitative scores of the readers, while the efficacy of the fsT2WI-TA model was comparable to that of the readers.

Novel pain assessment tool specific for pulp symptoms to aid diagnosis.

Although many pain assessment tools exist, none are specific to the relatively unique presentation of pulpal pain. The aim of this study was to develop and validate a novel pain assessment tool based on pulp symptoms. A preliminary list of items best-describing pulpitis was developed based on deductive and inductive approaches and the preliminary tool was piloted (n = 80). A final 11-item pain assessment tool was developed comprising 5 closed-ended items evaluating pain intensity to diverse stimuli (thermal and sweet) and 6 closed-ended items assessing various aspects of pulp pain (such as spontaneity, duration, referral, postural pain, pain upon biting and requirement for analgesics). The tool was tested on 300 adult patients (age range = 18-54 years) who presented with symptoms indicating some form of pulpitis. The 11 items were each scored from 1 to 4, yielding a total score between 11 and 44. These scores were subsequently compared to a set of diagnoses made utilizing established clinical reference standards, these include patient history, clinical examination, periapical radiographs, and pulp testing. All items in the tool reached an excellent content validity index score (≥0.83) for relevance. Following the pilot, six items were rephrased and five were removed. After final testing the constructed tool had a reliability coefficient of .8641, indicating a high level of internal consistency. Factor analysis extracted two factors that accounted for 59.61% of variance. The sensitivity and specificity was 95.36% and 86.58%, respectively. Likelihood ratio was 7.104 (LR+) and 0.05 (LR-) at cut-off point. The area under the ROC curve was 0.9714 with a SE of 0.0076. The cut off score by Youden index was 25 between reversible and irreversible pulpitis. The developed tool proved to be both valid and reliable. It is the first comprehensive multidimensional tool designed to standardize the pulp pain assessment protocol, covering various attributes of pulp pain and effectively distinguishing between reversible and irreversible pulpitis with a defined cut-off score. Furthermore, its use is anticipated to provide support in diagnosing ambiguous cases of inflamed pulp, which is especially helpful for less experienced dentists.

Application of a 3D Fusion Model to Evaluate the Efficacy of Clear Aligner Therapy in Malocclusion Patients: Prospective Observational Study.

Investigating the safe range of orthodontic tooth movement is essential for maintaining oral and maxillofacial stability posttreatment. Although clear aligners rely on pretreatment digital models, their effect on periodontal hard tissues remains uncertain. By integrating cone beam computed tomography-derived cervical and root data with crown data from digital intraoral scans, a 3D fusion model may enhance precision and safety. This study aims to construct a 3D fusion model based on artificial intelligence software that matches cone beam computed tomography and intraoral scanning data using the Andrews' Six Element standard. The model will be used to assess the 3D effects of clear aligners on tooth movement, to provide a reference for the design of pretreatment target positions. Between May 2022 and May 2024, a total of 320 patients who completed clear aligner therapy at our institution were screened; 136 patients (aged 13-35 years, fully erupted permanent dentition and periodontal pocket depth <3 mm) met the criteria. Baseline ("simulation") and posttreatment ("fusion") models were compared. Outcomes included upper core discrepancy (UCD), upper incisors anteroposterior discrepancy (UAP), lower Spee curve deep discrepancy (LSD), upper anterior teeth width discrepancy (UAW), upper canine width discrepancy (UCW), upper molar width discrepancy (UMW), and total scores. Subanalyses examined sex, age stage (adolescent vs adult), and treatment method (extraction vs nonextraction). The study was funded in May 2022, with data collection beginning the same month and continuing until May 2024. Of 320 initial participants, 136 met the inclusion criteria. Data analysis is ongoing, and final results are expected by late 2024. Among the 136 participants, 90 (66%) were female, 46 (34%) were male, 64 (47%) were adolescents, 72 (53%) were adults, 38 (28%) underwent extraction, and 98 (72%) did not. Total scores did not differ significantly by sex (mean difference 0.01, 95% CI -0.13 to 0.15; P=.85), age stage (mean difference 0.03, 95% CI -0.10 to 0.17; P=.60), or treatment method (mean difference 0.07, 95% CI -0.22 to 0.07; P=.32). No significant differences were found in UCD (mean difference 0.001, 95% CI -0.02 to 0.01; P=.90) or UAP (mean difference 0.01, 95% CI -0.03 to 0.00; P=.06) by treatment method. However, adolescents exhibited smaller differences in UCD, UAW, UCW, and UMW yet larger differences in UAP and LSD (df=134; P<.001). Extraction cases showed smaller LSD, UAW, and UCW but larger UMW differences compared with nonextraction (df=134; P<.001). The 3D fusion model provides a reliable clinical reference for target position design and treatment outcome evaluation in clear aligner systems. The construction and application of a 3D fusion model in clear aligner orthodontics represent a significant leap forward, offering substantial clinical benefits while establishing a new standard for precision, personalization, and evidence-based treatment planning in the field. Chinese Clinical Trial Registry ChiCTR2400094304, https://www.chictr.org.cn/hvshowproject.html?id=266090&v=1.0.

Clinical Reference Strategy for the Selection of Surgical Treatment for Nonsyndromic Sagittal Craniosynostosis: A Systematic Review and Network Meta-Analysis.

There is a lack of comprehensive comparative evidence regarding the effectiveness, intraoperative management, and safety of different surgical procedures for treating nonsyndromic sagittal synostosis. This study aims to evaluate existing clinical studies to provide evidence-based guidance for clinical practice. The authors performed a comprehensive search of 5 databases up to August 2024. Key outcomes included clinical effectiveness, measured by cephalic index (CI), and intraoperative management and safety indicators, such as intraoperative blood loss, operative time, and length of hospital stay. Direct and indirect effects, along with treatment rankings, were assessed using Bayesian pairwise and network meta-analysis models. Fifteen studies with 1436 patients were included, and 4 network meta-analysis models were used to compare 5 surgical techniques: open strip craniectomy (OSS), calvarial vault remodeling (CVR), spring-mediated cranioplasty (SMC), endoscopic strip craniectomy (ESC), and endoscopic spring-mediated cranioplasty (ESMC). No significant differences in postoperative CI were found between the surgical methods. However, CVR was associated with significantly greater blood loss, longer operative time, and longer hospital stays compared with OSS, SMC, and ESC. Current evidence does not demonstrate a clear superiority of one surgical method over another, with comparable treatment outcomes overall. However, CVR carries higher risks, and the choice of surgical approach should be individualized based on patient-specific factors and clinical judgment.

Guidelines for diagnosis and treatment on the groin hernia (2024 edition)

In recent years, the diagnosis and treatment of groin hernia have become more mature, and personalized treatment plans for different groin hernias have become more standardized. On the basis of the Guidelines for diagnosis and treatment on the adult groin hernia (2018 edition), more than 70 experts and scholars in China have discussed the consultation and modified the content of diagnosis and treatment of groin hernia in children and adolescents, diagnosis and treatment of scrotal hernia, management of hernia related complications, and postoperative education and follow-up in this new edition, combined with evidence-based medical evaluation standards. The relevant medical institutions and peers in China are requested to carry out the actual clinical reference.

Guidelines for diagnosis and treatment of abdominal wall incision hernia (2024 edition)

Incisional hernia is a type of iatrogenic disease, and its clinical treatment is complicated. In recent years, there have been new advances in the diagnosis, surgical methods, and materials science of incisional hernias. On the basis of the Guidelines for diagnosis and treatment of abdominal wall incisional hernia (2018 edition), more than 70 experts and scholars over the country have discussed the consultation and modified the issues such as complex abdominal wall conditions, loss of domain, principles of incisional hernia treatment, techniques of abdominal wall hernia defects closure, perioperative management, and follow-up in this new edition, combined with evidence-based medical evaluation standards. The relevant medical institutions and peers in China are requested to carry out the actual clinical reference.

Development and validation of a metabolic syndrome and its components to predict the efficacy of neoadjuvant chemotherapy in breast cancer: An observational, single-center, cohort study.

To assess whether metabolic syndrome can be used as a reference index to evaluate the efficacy of neoadjuvant chemotherapy treatment for breast cancer (BC). Seventy cases of female BC patients who received neoadjuvant chemotherapy treatment and surgical treatment at the Glandular Surgery Department of Hebei Provincial People's Hospital from January 2021 to December 2023 were retrospectively collected, and clinical data such as puncture pathology were recorded. The clinical data were analyzed by 1-way analysis using the χ2 test, and further multifactorial logistic regression analysis was performed for statistically significant differences. The independent risk factor metabolic syndrome (MetS) and its components were plotted in the receiver operating characteristic curve (ROC) curve and baseline graph by R Studio 4.41 software, and the meaningful components were plotted in the column graph by lasso regression analysis for internal validation, and the quality of the model was evaluated by the ROC curve and calibration graph, and then the clinical decision curve analysis was used to evaluate the clinical effectiveness of the model. The neoadjuvant efficacy was statistically associated with whether the patient was first diagnosed between 45 and 55 years of age, estrogen receptors (ER), progesterone receptors (PR) expression status, Her-2 expression status, and whether the patient had MetS, as determined by univariate analysis through χ2 (P < .05). On multifactorial binary logistic regression analysis, ER, PR status, Her-2 status, and the presence of MetS were statistically significant (P < .05) for the efficacy of neoadjuvant chemotherapy. Patients with MetS were less likely to achieve complete pathological remission than those without MetS. MetS and its components were analyzed by lasso regression analysis with RStudio 4.41 software to conclude that hypertension, hyperglycemia, and high-density lipoprotein were all correlates affecting the pathologic complete response (pCR), and a column-line graph was plotted, with a C-index of 0.76, indicating a good predictive efficacy. ER, PR status, Her-2 status and the presence of MetS are independent predictors for assessing the efficacy of neoadjuvant chemotherapy in BC, and MetS can be used as a predictor of the efficacy of neoadjuvant chemotherapy. Clinical references are provided.

Analysis of influencing factors for complications of anterior thoracolumbar tuberculosis surgery in adults.

This study analyzes the risk factors related to the complications of anterior thoracolumbar tuberculosis in adults and to provide clinical reference. A total of 98 adult patients with thoracolumbar tuberculosis undergoing anterior surgery in our hospital from February 2020 to December 2023 were selected, and the clinical data and postoperative complications were collected. The clinical characteristics were analyzed, and the risk factors related to surgical complications were analyzed by univariate analysis and multi-factor logistic regression model. A total of 54 patients had 75 postoperative complications of different degrees. Univariate analysis showed that patient age, preoperative hemoglobin (Hb) level, bone graft fusion method, intraoperative blood loss, and postoperative neurological function [Asian neurological function classification] were correlated with the occurrence of postoperative complications (P < .05). Multivariate Logistic regression analysis showed that age over 60 years old, preoperative Hb < 100 g/L, blood loss ≥ 800 mL, bone graft fusion method were independent risk factors for anterior postoperative complications of thoracolumbar tuberculosis (P < .05). The independent risk factors for surgical complications of anterior thoracolumbar tuberculosis were age over 60 years old, preoperative Hb < 100 g/L, blood loss ≥ 800 mL, titanium cage by bone graft fusion. Controlling these variable factors before operation can reduce the incidence of postoperative complications.

Multiplexed Dilute-and-Shoot Liquid Chromatography-Multiple-Reaction Monitoring Mass Spectrometry Clinical Assay for Metanephrines and Catecholamines in Human Urine.

Background: Quantifying urinary catecholamines and metanephrines is essential for the clinical screening and diagnosis of neuroendocrine tumours. HPLC with electrochemical detection (HPLC-ECD) is commonly used for this type of analysis but requires extensive sample cleanup. Simple and rapid dilute-and-shoot LC-multiple-reaction monitoring (MRM)-MS assays have been developed for quantitating these analytes in urine but have not yet been validated according to the Clinical and Laboratory Standards Institute (CLSI) guidelines. Methods: A simple dilute-and-shoot sample preparation without derivatization was used. C18 RP-UPLC-MRM-MS and positive-ion ESI were used, usually with two transitions per analyte being monitored. Certified deuterated internal standards were used for each analyte. Results: This assay was validated according to the CLSI C62-A guidelines, including accuracy/trueness, imprecision, sensitivity, specificity, carryover, stability, and linearity. The final MRM-MS method was compared to the established HPLC-ECD clinical chemistry reference method. The run time was reduced from 25 min to 5 min. Conclusions: A simple, robust, rapid, and cost-effective LC-MRM-MS assay for measuring urinary catecholamines and metanephrines was developed and validated according to the CLSI guidelines. This validated method requires minimal sample manipulation before analysis and provides sensitivity, specificity, and improved precision. The implementation of this assay in clinical laboratories will facilitate early and accurate diagnosis.

Physiologically-based pharmacokinetic modeling to predict the exposure and provide dosage regimens of tacrolimus in pregnant women with infection disease.

Tacrolimus is extensively used for the prevention of graft rejection following solid organ transplantation in pregnant women. However, knowledge gaps in the dosage of tacrolimus for pregnant patients with different CYP3A5 genotypes and infection conditions have been identified. This study aimed to develop a pregnant physiologically based pharmacokinetic (PBPK) model to characterize the maternal and fetal pharmacokinetics of tacrolimus during pregnancy and explore and provide dosage adjustments. We developed PBPK models for nonpregnant patients and validated them via data from previous clinical studies using PK-Sim and Mobi software. To extrapolate to pregnancy, we considered anatomical, physiological, and metabolic alterations and simulated tacrolimus by adding six groups of IL-6 concentrations (0, 5, 25, 50, 500, and 5000 pg/mL). Models were verified by assessing goodness-of-fit plots and ratios of predicted-to-observed pharmacokinetic parameters. The developed PBPK models adequately describe the available clinical data; the fold errors of the predicted and observed values of the area under the curve and peak plasma concentration were between 0.59 and 1.64, and the average folding error and the absolute average folding error values for all concentration-time data points were 1.15 and 1.36, respectively. The simulation results indicated that the area under the steady-state concentration‒time curve and trough concentrations decreased from the first to the third trimester of pregnancy. The trough concentrations were not within the therapeutic range (4-11 ng/mL) in pregnant patients with the CYP3A5 genotype for most of the infection conditions and exceeded its effective concentration in all the CYP3A5 nonexpressers. Based on the model-derived dosing regimen, the tacrolimus trough concentration in pregnant patients with different CYP3A5 genotypes could fall into the therapeutic window, which provided a clinical practice reference for dosage adjustments during pregnancy.

Prediction of acute kidney injury in intensive care unit patients based on interpretable machine learning.

Acute kidney injury (AKI) poses a lethal risk in intensive care unit (ICU) patients, where early detection is challenging. This study was to establish a prediction model for AKI 24 hours in advance for ICU patients and to help clinicians monitor patients at an early stage by key features. In this study, the Medical Information Mart for Intensive Care (MIMIC) databases were used to construct a dataset of critically ill patients. Predictive models were constructed using five machine learning algorithms based on MIMIC-IV data, and the best predictive model was selected by multiple model evaluation metrics. MIMIC-III data were used for external validation. We conducted an interpretability analysis of the model using SHapley Additive exPlanations (SHAP) to clarify key features and decision-making mechanisms. A total of 18,186 patient data were included in this study. The analysis combining calibration and decision curves demonstrated that the eXtreme Gradient Boosting (XGBoost) exhibited superior performance among the five algorithms, achieving an area under the receiver operating characteristic curve of 0.88. Interpretability analysis based on the XGBoost model showed diuretic use, mechanical ventilation, vasopressor use, age, and antibiotic use as the most important decision factors of the model. The SHAP summary plot was used to illustrate the effects of the top 19 features attributed to the XGBoost. The XGBoost algorithm can predict the occurrence of AKI more accurately. Interpretative analysis of the model reveals the mechanisms of key features, and reflects the individual differences between patients, providing an important clinical reference.

Joint image reconstruction and segmentation of real-time cardiac MRI in free-breathing using a model based on disentangled representation learning.

To investigate image quality and agreement of derived cardiac function parameters in a novel joint image reconstruction and segmentation approach based on disentangled representation learning, enabling real-time cardiac cine imaging during free-breathing. A multi-tasking neural network architecture, incorporating disentangled representation learning, was trained using simulated examinations based on data from a public repository along with MR scans specifically acquired for model development. An exploratory feasibility study evaluated the method on undersampled real-time acquisitions using an in-house developed spiral bSSFP pulse sequence in eight healthy participants and five patients with intermittent atrial fibrillation. Images and predicted LV segmentations were compared to the reference standard of ECG-gated segmented Cartesian cine with repeated breath-holds and corresponding manual segmentation. On a 5-point Likert scale, image quality of the real-time breath-hold approach and Cartesian cine was comparable in healthy participants (RT-BH: 1.99 ±.98, Cartesian: 1.94 ±.86, p=.052), but slightly inferior in free-breathing (RT-FB: 2.40 ±.98, p<.001). In patients with arrhythmia, both real-time approaches demonstrated favourable image quality (RT-BH: 2.10 ± 1.28, p<.001, RT-FB: 2.40 ± 1.13, p<.01, Cartesian: 2.68 ± 1.13). Intra-observer reliability was good (ICC=.77,95%-confidence interval [.75,.79], p<.001). In functional analysis, a positive bias was observed for ejection fractions derived from the proposed model compared to the clinical reference standard (RT-BH mean: 58.5 ± 5.6%, bias: +3.47%, 95%-confidence interval [-.86, 7.79%], RT-FB mean: 57.9 ± 10.6%, bias: +1.45%, [-3.02, 5.91%], Cartesian mean: 54.9 ± 6.7%). The introduced real-time MR imaging technique enables high-quality cardiac cine data acquisitions in 1-2minutes, eliminating the need for ECG gating and breath-holds. This approach offers a promising alternative to the current clinical practice of segmented acquisition, with shorter scan times, improved patient comfort, and increased robustness to arrhythmia and patient non-compliance.